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1.  An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects 
BMC Neurology  2011;11:126.
The ability to self-inject in patients with multiple sclerosis (MS) has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen), a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNβ-1a, Avonex) in MS patients.
This was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNβ-1a prefilled syringes. Patients received weekly 30 mcg IM IFNβ-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNβ-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNβ-1a using the device. On Day 15, patients self-administered IM IFNβ-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNβ-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout.
Seventy-one (96%) patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3) on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy). Ninety-four percent of patients preferred the prefilled pen over the prefilled syringe. Induction of serum neopterin levels, serving as a biomarker for type 1 interferon action, was similar to that of the prefilled syringe. The prefilled pen demonstrated a safety profile comparable to the prefilled syringe.
The prefilled pen is a safe and effective device for administration of IM IFNβ-1a and represents an alternative method for self-injection for MS patients using this therapy.
Trial registration
This study is registered at, identifier: NCT00828204
PMCID: PMC3213083  PMID: 21999176
2.  Lack of Pain Reduction by a Vibrating Local Anesthetic Attachment: A Pilot Study 
Anesthesia Progress  2005;52(2):62-64.
A vibrating dental local anesthesia attachment (Vibraject, LLC, Calif) based on the concept of the gate-control theory has been used in clinical practice. The theoretical advantage of the vibrating needle is that it reduces the injection pain. We evaluated the effectiveness of Vibraject in combination with an electrical injection device. Injections were given into the alveolar mucosa adjacent to the root apex of the maxillary lateral incisor in 10 volunteers. Vibraject was randomly applied to either the left or right side of the injection. No statistically significant decrease in pain scores was found at needle insertion or anesthetic injection. The clinical efficacy of Vibraject remains controversial.
PMCID: PMC2527045  PMID: 16048153
Local anesthesia; Injection; Pain; Vibrating needle
3.  What Can We Learn from Patient-Reported Outcomes of Insulin Pen Devices? 
Although a variety of effective treatment options are available for patients with type 1 or type 2 diabetes, many patients in the United States have difficulty reaching their glycemic goals. Patient adherence to insulin therapy, which often involves self-administered subcutaneous injections of insulin using either a vial and syringe or an insulin pen device, is often poor. Various factors associated with the type of injection device have been shown to influence the rate of patient adherence to insulin therapy. This article reviews patient-reported outcome (PRO) evidence from pediatric and adult studies that compared insulin pen devices with vial and syringe use. In a majority of these cases, patients preferred the pen devices over vial and syringe, stating advantages such as ease of use, convenience, greater confidence in their ability to properly administer the drug, and a greater perceived social acceptance. The pens were considered less painful than syringes and were associated with less needle fear. In addition, PRO evidence has directed pen technology design, leading to development of more advanced insulin pen devices. By appreciating the correlation between adherence to insulin regimens and a patient’s device preference, clinicians can make improved treatment recommendations to facilitate achievement and maintenance of glycemic targets.
PMCID: PMC3262728  PMID: 22226279
adherence; diabetes; insulin therapy; pen; syringe
4.  A clinical comparison of pain perception and extent of area anesthetized by Wand® and a traditional syringe 
In the contemporary dental practice, alleviation of pain is the most important factor to ameliorate patient's condition and to gain one's confidence towards the skills of the operator. Such confidence aids to the ultimate success of the treatment procedures.
Aims and Objectives:
This study compares the pain response of a group of 10 subjects to the Wand® with the response to traditional syringe injections and also compares the extent of the area anesthetized.
Materials and Methods:
10 subjects were selected for the study and 20 injections were given contralaterally to them, 10 with Wand®, and rest with the traditional aspirating syringe. Each subject received 2 injections on the palate, Left side with Wand® (test) and Right side with Traditional syringe (control). All injections were given by the same investigator without the use of topical anesthetic spray/gel. Pain perception levels were recorded with a visual analogue scale. Also the extent of area anesthetized with a single palatal injection was assessed by probing.
The results showed injections with the syringe were more painful than injections with the Wand® in 2 of 10 subjects. Also the extent of the area anesthetized by both the techniques was similar except in 2 patients.
The Wand® results in less painful injections; however, mean ratings of pain for both the groups, were mostly below the annoying level of pain. Also, the areas covered by the anesthetic effect of both the injections were comparatively similar.
PMCID: PMC3459500  PMID: 23055586
Anesthesia; pain; pain perception; visual analogue scale; Wand® technique
5.  Comparison of follitropin β administered by a pen device with follitropin β administered by a conventional syringe in patients undergoing IVF-ET 
To compare the effectiveness and convenience of a pen device for the self-administration of follitropin β with a conventional syringe delivering follitropin β solution in patients undergoing IVF-ET.
GnRH agonist long protocol was used for controlled ovarian stimulation (COS) in all subjects. A total of 100 patients were randomized into the pen device group or the conventional syringe group on the first day of COS. Local tolerance reactions were assessed within 5 minutes, at 1 hour and at 3 hours after each injection. On the day of hCG injection, patients were asked to rate their overall pain and convenience experienced with self-injection on a visual anlaogue scale (VAS).
There were no differences in patients' characteristics between the two groups. The duration of COS was significantly shorter in the pen device group than in the conventional syringe group. Patients included in the pen device group needed a significantly smaller amount of follitropin β. However, no differences between the two groups were found in IVF results and pregnancy outcome. The incidence of local pain within 5 minutes, at 1 hour and at 3 hours after the injection was significantly lower in the pen device group. VAS scores indicated that injections using the pen device were significantly less painful and more convenient.
The pen device for self-administration of follitropin β is less painful, safer and more convenient for the patients, and can be more effective because of the shorter duration and smaller dose of follitropin β when compared with the conventional syringe.
PMCID: PMC3283050  PMID: 22384416
Ovulation Induction; In Vitro Fertilization; Injections, Subcutaneous; Follicle Stimulating Hormone, Beta Subunit; Human
6.  Evaluation of a magnetic resonance-compatible dentoalveolar tactile stimulus device 
BMC Neuroscience  2010;11:142.
Few methods exist to study central nervous system processes following dentoalveolar tactile stimulation using functional magnetic resonance imaging (fMRI), likely due to inherent technical difficulties. Our primary goal was to develop and perform feasibility testing of a novel device capable of delivering valid and reliable dentoalveolar stimuli at dental chair-side and during MRI. Details of a device designed to deliver dentoalveolar dynamic pressure stimuli are described. Device testing took place in three settings: a) laboratory testing to assess range of stimulus force intensities, b) dental chair-side to assess reliability, validity and discriminant ability in force-pain relationship; and c) MRI to evaluate magnetic compatibility and ability to evoke brain activation in painfree subjects similar to those described in the literature.
A novel device capable of delivering valid and reliable dentoalveolar somatosensory stimulation was developed (ICC = 0.89, 0.78-1 [95% CI]). Psychophysical data analysis showed high discriminant ability in differentiating painfree controls from cases with chronic dentoalveolar pain related to deafferenting dental procedures (sensitivity = 100%, specificity = 86.7%, area under ROC curve = 0.99). FMRI results of dentoalveolar dynamic pressure pain in painfree subjects revealed activation of brain areas typically associated with acute pain processing including thalamus, primary/secondary somatosensory, insular and prefrontal cortex.
A novel psychophysical method to deliver dynamic dentoalveolar pressure stimulation was developed and validated, allowing non-invasive MRI-based exploration of central nervous system function in response to intraoral somatosensation.
The organization of the trigeminal system is unique as it provides somatosensory innervation to the face, masticatory and oral structures, the majority of the intracranial contents [1] and to specialized structures (tongue, nasal mucosa, auricle, tympanic membrane, cornea and part of the conjunctiva) [2]. Somatic sensory information transmitted by the trigeminal nerve is crucial for normal orofacial function; however, the mechanisms of many chronic pain conditions affecting areas innervated by this sensory system are not well understood [3-5]. The clinical presentation of chronic intraoral pain in the area of a tooth or in a site formally occupied by a tooth with no clinical or radiological signs of pathology, referred to as atypical odontalgia (AO) [6,7], is one such chronic pain condition of particular interest to dentists that is difficult to diagnose and manage. Recent research suggests both peripheral and central nervous system mechanisms being involved in AO pathophysiology [8-10], but the majority of mechanism-based research of patients with AO has focused on the "peripheral aspect" [7].
Functional magnetic resonance imaging (fMRI) is an established research technique to study the central aspects of pain [11]. Of existing neuroimaging techniques, fMRI provides good spatial resolution of cortical and subcortical structures critical in the processing of nociception, acceptable temporal resolution, does not involve ionizing radiation, and can be performed using most MRI systems that already exist in research centers and the community. For these reasons, we sought to develop a protocol that allows us to use this tool to investigate the central mechanisms involved in the processes of intraoral pain arising from the dentoalveolar region. Using this device, our long-term objective is to improve our understanding of the underlying mechanisms of persistent dentoalveolar pain.
In the past few years several studies used fMRI to investigate the human trigeminal system [12,13], with a limited subset focusing on intraoral stimulation - specifically on the dentoalveolar processes, such as lip, tongue and teeth stimulation [14] or only teeth [15-17]. Some reasons for scarce literature on this topic may be the technical challenges involved in delivering facial/intraoral stimulation inside a MR scanner [17,18]: possibility of magnetic interference, detriment of image quality, subject discomfort and reduced working space between the subject's head and the radiofrequency coil. As a consequence a MR-compatible device would need to not only overcome these challenges but also be capable of delivering a controlled and reproducible stimuli [19], as reliability/reproducibility is a necessary feature of sensory testing [20].
Existing MR-compatible methods of dentoalveolar stimulation are limited and do not adequately deliver stimuli across a range of non-painful to painful intensities and/or cannot be adjusted to reach posterior aspects of the dentoalveolar region. Therefore our goal was to develop and test the feasibility of a device able to: 1) provide reliable and valid dentoalveolar stimuli, 2) deliver such stimulation within the restricted space of an MR head coil, 3) be compatible for use within an MR environment, and 4) produce brain activation in painfree controls consistent to those observed by others using fMRI.
PMCID: PMC2988799  PMID: 21029454
7.  A comparison of the efficacy of topical application of Lignocaine Hydrochloride 5% gel and Bupivacaine Hydrochloride 5% gel for extraction of teeth 
With the advancements in dentistry the treatments are done with high perfections and patient comfort. Noninvasive, methods reduce fear and anxiety of the patient on phobia of syringes and injections. Topical anesthesia satisfies all the above criteria.
Aim and objective
Comparison of the efficacy of topical application of lignocaine hydrochloride 5% gel and bupivacaine hydrochloride 5% gel for extraction of teeth.
Materials and methods
Lignocaine hydrochloride 5% gel and bupivacaine hydrochloride 5% gel are prepared with carbopol (thickening agent). 510 extractions with lignocaine hydrochloride gel 5% and bupivacaine hydrochloride gel 5% in equal numbers was undertaken. Parameters of onset of anesthesia, peak effects, pain, and disappearance of numbness, local irritation, bleeding and periodontal status of teeth to be extracted were taken into consideration.
Onset and peak effect were faster with 5% lignocaine hydrochloride gel. 5% bupivacaine hydrochloride gel had longer duration of analgesia. Patients experienced more pain with bupivacaine. Grade 1 mobile posterior teeth were painful during extraction.
5% lignocaine hydrochloride gel is better than 5% bupivacaine hydrochloride gel as a topical anesthetic for extraction of grade II and grade III mobile teeth.
PMCID: PMC3244105  PMID: 22190770
Topical anesthesia; Lignocaine hydrochloride; Bupivacaine hydrochloride
8.  Evaluation of pharmacokinetics, user handling, and tolerability of peginterferon alfa-2a (40 kDa) delivered via a disposable autoinjector device 
Peginterferon alfa-2a (40 kDa) is currently administered using a prefilled syringe. The peginterferon alfa-2a disposable autoinjector is a new safety-engineered device designed to facilitate injection and reduce the risk of needlestick injuries. The analysis of two open-label Phase I trials evaluated the pharmacokinetics, successful administration, and tolerability of peginterferon alfa-2a when using the autoinjector. The studies were performed to support the filing and registration of the autoinjector device.
In trial 1, 50 healthy adult subjects received one 180 μg dose of peginterferon alfa-2a via the autoinjector. Serial blood samples were collected predose, up to 336 hours following drug administration, and at follow-up (28 ± 3 days post-dosing) for noncompartmental pharmacokinetic analysis. Trial 2 randomized 60 adult patients with chronic hepatitis C to 180 μg peginterferon alfa-2a once weekly by the autoinjector or prefilled syringe for 3 weeks followed by the alternative device (prefilled syringe or autoinjector, respectively) for 3 weeks. Patients also received ribavirin. Administration by the devices was evaluated under direct observation by a study staff member and by patient subjective assessment.
In trial 1, following a single dose of peginterferon alfa-2a, the maximum plasma concentration was 16.1 ± 5.3 ng/mL (mean ± standard deviation), and area under the concentration time curve (0–168 hours) was 1996 ± 613 ng · hour/mL, similar to that reported using a vial/syringe or prefilled syringe. In trial 2, few patients showed handling difficulties with either device. Generally, patients were observed to be more satisfied and confident, followed instructions better, and successfully initiated injection with the autoinjector versus the prefilled syringe. Patients reported the autoinjector to be more convenient and easier to use. No pain or discomfort was experienced using the autoinjector. The autoinjector safety profile was consistent with that known for peginterferon alfa-2a/ribavirin.
These results indicate that peginterferon alfa-2a can be successfully and safely delivered via the autoinjector and that the device is easy to handle.
PMCID: PMC3234901  PMID: 22163158
peginterferon alfa-2a; disposable autoinjector; hepatitis C; pharmacokinetics; user handling
9.  Pain Elimination during Injection with Newer Electronic Devices: A Comparative Evaluation in Children 
Aim: The present study was taken up to clinically evaluate and compare effectiveness of transcutaneous electrical nerve stimulator (TENS) and comfort control syringe (CCS) in various pediatric dental procedures as an alternative to the conventional method of local anesthesia (LA) administration.
Materials and methods: Ninety healthy children having at least one deciduous molar tooth indicated for extraction in either maxillary right or left quadrant in age group of 6 to 10 years were randomly divided into three equal groups having 30 subjects each. Group I: LA administration using conventional syringe, group II: LA administration using TENS along with the conventional syringe, group III: LA administration using CCS. After LA by the three techniques, pain, anxiety and heart rate were measured.
Statistical analysis: The observations, thus, obtained were subjected to statistical analysis using analysis of variance (ANOVA), student t-test and paired t-test.
Results: The mean pain score was maximum in group I followed by group II, while group III revealed the minimum pain, where LA was administered using CCS. Mean anxiety score was maximum in group I followed by group II, while group III revealed the minimum score. Mean heart rate was maximum in group I followed in descending order by groups II and III.
Conclusion: The study supports the belief that CCS could be a viable alternative in comparison to the other two methods of LA delivery in children.
How to cite this article: Bansal N, Saha S, Jaiswal JN, Samadi F. Pain Elimination during Injection with Newer Electronic Devices: A Comparative Evaluation in Children. Int J Clin Pediatr Dent 2014;7(2):71-76.
PMCID: PMC4212160  PMID: 25356003
Transcutaneous electrical nerve stimulation; Comfort control syringe; Conventional syringe; Anxiety
10.  Adverse event associated with a change in nonprescription syringe sale policy 
To report and describe the possible correlation of a change in syringe sale policy at a community pharmacy with an adverse clinical outcome.
Providence, RI, in summer 2009.
Patient description
27-year-old white woman with a long-standing history of chronic relapsing opiate addiction and human immunodeficiency virus (HIV)/hepatitis C virus (HCV) coinfection.
Case summary
The patient presented to the hospital emergency department with 5 days of severe diffuse pain, swelling in her hands and feet, and several days of rigors with fevers, sweats, and chills. She was diagnosed with sepsis resulting from a disseminated methicillin-resistant Staphylococcus aureus (MRSA) infection. The patient was treated with intravenous antibiotics, neurosurgical drainage of an epidural abscess, intensive care unit care for 1 week, and acute hospitalization for 8 weeks.
Main outcome measures
Not applicable.
A few weeks before the patient was hospitalized, pharmacists at her local neighborhood pharmacy decided to stop selling syringes in packages of 10. Instead, syringes were sold at a minimum quantity of 100. The patient did not know where to obtain sterile syringes and began reusing syringes.
The patient introduced pathogenic bacteria from her skin into her bloodstream through unsafe injection practices. The change in syringe sale policy at her local pharmacy likely inadvertently contributed to this severe and life-threatening situation. Consideration of the implications of syringe sale policy must include an understanding of the barriers that influence individual pharmacist’s decisions regarding particular store policies that affect over-the-counter syringe sales. Legalized sale of nonprescription syringes in community pharmacies alone is not enough to curb the epidemic of unsafe injection practices in the United States. All medical risks that are inherent in the use of unsafe syringes, including blood-borne viral pathogens (e.g., HIV, HCV) and bacterial infections (e.g., MRSA), should be considered.
PMCID: PMC3008769  PMID: 20833621
Nonprescription syringe sales; OTC products; case report; bacterial infections; pharmacists; injection drug users; Rhode Island
11.  Understanding and meeting injection device needs in multiple sclerosis: a survey of patient attitudes and practices 
All established disease-modifying drugs for multiple sclerosis require parenteral administration, which can cause difficulties for some patients, sometimes leading to suboptimal adherence. A new electronic autoinjection device has been designed to address these issues.
Patients with relapsing multiple sclerosis currently receiving subcutaneous or intramuscular interferon beta-1a, interferon beta-1b, or glatiramer acetate completed an online questionnaire (July 4–25, 2008) that surveyed current injection practices, experiences with current injection methods, and impressions and appeal of the new device.
In total, 422 patients completed the survey, of whom 44% used autoinjectors, 43% prefilled syringes, and 13% syringes and vials; overall, 66% currently self-injected. Physical and psychological barriers to self-injection included difficulty with injections, needle phobia, and concerns over correct injection technique. Only 40% of respondents were “very satisfied” with their current injection method. The new electronic autoinjector was rated as “very appealing” by 65% of patients. The benefits of the new device included the ability to customize injection settings and to review dosing history.
New technologies may help patients overcome physical and psychological barriers to self-injection. The combination of a reliable and flexible autoinjection device with dose-monitoring technology may improve communication between health care professionals and patients, and improve treatment adherence.
PMCID: PMC3090378  PMID: 21573048
adherence; autoinjection; subcutaneous interferon beta-1a; multiple sclerosis
12.  Pain and Efficacy Rating of a Microprocessor-Controlled Metered Injection System for Local Anaesthesia in Minor Hand Surgery 
Pain Research and Treatment  2011;2011:362396.
Purpose. Little attention has been given to syringe design and local anaesthetic administration methods. A microprocessor-controlled anaesthetic delivery device has become available that may minimize discomfort during injection. The purpose of this study was to document the pain experience associated with the use of this system and to compare it with use of a conventional syringe. Methods. A prospective, randomized clinical trial was designed. 40 patients undergoing carpal tunnel release were block randomized according to sex into a two groups: a traditional syringe group and a microprocessor-controlled device group. The primary outcome measure was surgical pain and local anaesthetic administration pain. Secondary outcomes included volume of anaesthetic used and injection time. Results. Analysis showed that equivalent anaesthesia was achieved in the microprocessor-controlled group despite using a significantly lower volume of local anaesthetic (P = .0002). This same group, however, has significantly longer injection times (P < .0001). Pain during the injection process or during surgery was not different between the two groups. Conclusions. This RCT comparing traditional and microprocessor controlled methods of administering local anaesthetic showed similar levels of discomfort in both groups. While the microprocessor-controlled group used less volume, the total time for the administration was significantly greater.
PMCID: PMC3197004  PMID: 22110923
13.  Anesthetic Cartridge System Under Evaluation 
Anesthesia Progress  1981;28(1):5-10.
The problem of glass breakage in the local anesthetic cartridge system was evaluated under laboratory conditions with a mechanical testing machine. The anticipated breakage of the glass did not occur with any frequency, as the rubber stopper produced more uniform failures of the system. The glass cartridge appeared to be quite reliable and resistant to breakage.
Local anesthetics have been used for many years to provide patients temporary freedom from pain. Local anesthetic solutions are in wide use in both dentistry and medicine and are the most frequently used drugs in dentistry. Various estimates place the number of injections at approximately one half million daily or 125 million injections per year.
These drugs and the armamentarium necessary to administer them have proven to be safe and reliable. Only rarely are there reports of sensitivity to the anesthetic solution or breakage of needles.. Sterility of the solutions has not been a problem as they are carefully processed and evaluated at the factory. Although there are sporadic reports of loss of sterility, this has been attributed to the reuse of the anesthetic cartridges on more than one patient. Monheim states “The success of the cartridge system in dentistry has been due to the sincerity, honesty, and high standards of the manufacturers in giving the profession a near-perfect product.” However, on occassion a glass cartridge will break or shatter when inserting the harpoon into the rubber stopper or even during injection. Cooley et al reported on eye injuries occurring in the dental office, one of which was due to glass from a local anesthetic cartridge that exploded and propelled particles into the patient's eye. Forrest evaluated syringes, needles, and cartridges and reported that one brand (made in Britain) fractured more often than any other, but that the fracture rate was too low to be of any consequence.
It is apparent that glass cartridges will fracture or burst from time to time. This study evaluates the cartridge system with carefully controlled laboratory procedures. The cartridges were tested under various pressures and conditions in an attempt to determine the causes of failure and when such failure may be anticipated.
PMCID: PMC2235753  PMID: 6939350
14.  Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients 
Intraoral local anesthesia is essential for delivering dental care. Needless devices have been developed to provide anesthesia without injections. Little controlled research is available on its use in dental restorative procedures in adult patients. The aims of this study were to compare adult patients acceptability and preference for needleless jet injection with classical local infiltration as well as to evaluate the efficacy of the needleless anesthesia.
Materials and Methods:
Twenty non fearful adults with no previous experience of dental anesthesia were studied using split-mouth design. The first procedure was performed with classical needle infiltration anesthesia. The same amount of anesthetic solution was administered using MADA jet needleless device in a second session one week later, during which a second dental restorative procedure was performed. Patients acceptance was assessed using Universal pain assessment tool while effectiveness was recorded using soft tissue anesthesia and pulpal anesthesia. Patients reported their preference for the anesthetic method at the third visit. The data was evaluated using chi square test and student's t-test.
Pressure anesthesia was more accepted and preferred by 70% of the patients than traditional needle anesthesia (20%). Both needle and pressure anesthesia was equally effective for carrying out the dental procedures.
Patients experienced significantly less pain and fear (p<0.01) during anesthetic procedure with pressure anesthesia. However, for more invasive procedures needle anesthesia will be more effective.
PMCID: PMC4001276  PMID: 24778516
Injection pain; jet injection; local anesthesia; needleless anesthesia; oral anesthesia; pressure anesthesia
15.  Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731] 
BMC Surgery  2007;7:22.
Inguinal hernia repair is one of the most frequently performed procedures in Switzerland (15'000/year). The most common complication postoperatively is development of chronic pain in up to 30% of all patients irrespective of the operative technique.
264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20 ml Carbostesin® 0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher® device (Cefar Medical AB, Lund, Sweden).
The study started on July 2006. In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.
Using a group sequential study design the minimum number of patients are enrolled to reach a valid conclusion before the end of the study.
To limit subjectivity, both a VAS and the Pain Matcher® device are used for the evaluation of pain. This allows us also to compare these two methods and further assess the use of Pain Matcher® in clinical routine.
The occurrence of chronic pain after inguinal hernia repair has been in focus of several clinical studies but the reduction of it has been rarely investigated. We hope to significantly reduce the occurrence of this complication with our investigated intervention.
Trial Registration
Our trial has been registered at The trial registration number is: [NCT00484731].
PMCID: PMC2198905  PMID: 17986324
16.  Safer injections following a new national medicine policy in the public sector, Burkina Faso 1995 – 2000 
BMC Public Health  2005;5:136.
The common failure of health systems to ensure adequate and sufficient supplies of injection devices may have a negative impact on injection safety. We conducted an assessment in April 2001 to determine to which extent an increase in safe injection practices between 1995 and 2000 was related to the increased access to injection devices because of a new essential medicine policy in Burkina Faso.
We reviewed outcomes of the new medicine policy implemented in1995. In April 2001, a retrospective programme review assessed the situation between 1995 and 2000. We visited 52 health care facilities where injections had been observed during a 2000 injection safety assessment and their adjacent operational public pharmaceutical depots. Data collection included structured observations of available injection devices and an estimation of the proportion of prescriptions including at least one injection. We interviewed wholesaler managers at national and regional levels on supply of injection devices to public health facilities.
Fifty of 52 (96%) health care facilities were equipped with a pharmaceutical depot selling syringes and needles, 37 (74%) of which had been established between 1995 and 2000. Of 50 pharmaceutical depots, 96% had single-use 5 ml syringes available. At all facilities, patients were buying syringes and needles out of the depot for their injections prescribed at the dispensary. While injection devices were available in greater quantities, the proportion of prescriptions including at least one injection remained stable between 1995 (26.5 %) and 2000 (23.8 %).
The implementation of pharmaceutical depots next to public health care facilities increased geographical access to essential medicines and basic supplies, among which syringes and needles, contributing substantially to safer injection practices in the absence of increased use of therapeutic injections.
PMCID: PMC1343564  PMID: 16364178
17.  Dentomaxillofacial imaging with panoramic views and cone beam CT 
Insights into Imaging  2015;6(1):1-16.
Panoramic and intraoral radiographs are the basic imaging modalities used in dentistry. Often they are the only imaging techniques required for delineation of dental anatomy or pathology. Panoramic radiography produces a single image of the maxilla, mandible, teeth, temporomandibular joints and maxillary sinuses. During the exposure the x-ray source and detector rotate synchronously around the patient producing a curved surface tomography. It can be supplemented with intraoral radiographs. However, these techniques give only a two-dimensional view of complicated three-dimensional (3D) structures. As in the other fields of imaging also dentomaxillofacial imaging has moved towards 3D imaging. Since the late 1990s cone beam computed tomography (CBCT) devices have been designed specifically for dentomaxillofacial imaging, allowing accurate 3D imaging of hard tissues with a lower radiation dose, lower cost and easier availability for dentists when compared with multislice CT. Panoramic and intraoral radiographies are still the basic imaging methods in dentistry. CBCT should be used in more demanding cases. In this review the anatomy with the panoramic view will be presented as well as the benefits of the CBCT technique in comparison to the panoramic technique with some examples. Also the basics as well as common errors and pitfalls of these techniques will be discussed.
Teaching Points
• Panoramic and intraoral radiographs are the basic imaging methods in dentomaxillofacial radiology.
• CBCT imaging allows accurate 3D imaging of hard tissues.
• CBCT offers lower costs and asmaller size and radiation dose compared with MSCT.
• The disadvantages of CBCT imaging are poor soft tissue contrast and artefacts.
• The Sedentexct project has developed evidence-based guidelines on the use of CBCT in dentistry.
PMCID: PMC4330237  PMID: 25575868
Panoramic radiography; Cone beam computed tomography; Dentomaxillofacial imaging; Diagnosis; Radiation dose
18.  Dental anxiety: a comparison of students of dentistry, biology, and psychology 
Dental anxiety is an important challenge for many patients and clinicians. It is thus of importance to know more about dental students’ own experiences with dental anxiety and their understanding of dental anxiety. The aim was to investigate differences in dental anxiety levels between dental students, psychology students, and biology students at a Norwegian university.
Materials and methods
A total of 510 students of dentistry, psychology, and biology at the University of Tromsø received a questionnaire consisting of the Modified Dental Anxiety Scale, demographic questions, and questions relating to their last visit to the dentist/dental hygienist; 169 students gave complete responses. Nonparametric tests were used to investigate differences between the student groups.
The respondents were 78% female and 22% male; their mean age was 24 years. The dental students showed a significantly lower degree of dental anxiety than the psychology (P<0.001) and biology students (P<0.001). A significant decrease in dental anxiety levels was found between novice and experienced dentistry students (P<0.001).
The dental students had less dental anxiety compared to psychology students and biology students. Experienced dental students also had less dental anxiety than novice dental students. This could indicate that the dentistry program structure at the university may influence dental anxiety levels.
Dental anxiety seemed to be less frequent in dentistry students compared to students of biology or clinical psychology. The practice-oriented dentistry education at the university might contribute to the differences in anxiety levels between new and experienced dentistry students.
PMCID: PMC4181736  PMID: 25285013
dentistry; Modified Dental Anxiety Scale; practice; training; education; questionnaire-study
19.  A clinical comparison of ketofol (ketamine and propofol admixture) versus propofol as an induction agent on quality of laryngeal mask airway insertion and hemodynamic stability in children 
In spite of being the preferred induction agent for LMA insertion, propofol has many undesirable side effects including dose-related cardiorespiratory depression and local pain at injection site. Ketofol as a novel induction agent has been introduced recently with comparable efficacy and improved hemodynamic control
To investigate ketofol as a suitable induction agent alternative to propofol for insertion of LMA in children considering insertion conditions, hemodynamic stability, local pain at injection site, and recovery.
Materials and Methods:
In this randomized, double-blind study, 100 children were randomly assigned into two groups of 50 patients each in which induction was performed with either propofol or ketofol. Providers were given one 20 ml syringe [represent either 2 mg/kg of propofol (P group) or 0.75 mg/kg of ketamine and 1.5 mg/kg of propofol (KP group)] and one 10 ml syringe for rescue if needed [represent 1 mg/kg of propofol (P group) or 0.25 mg/kg of ketamine and 0.5 mg/kg of propofol (KP group)]. After monitoring with bispectral index (BIS), general anesthesia was induced by infusion with a syringe perfuser at a constant rate of 250 ml/h with either of the two agents till the BIS values decreased to 40. Mean arterial pressure (MAP), heart rate (HR) were measured every 30 seconds up to 5 minutes after LMA placement. The time till BIS values decreased to 40 was measured. All children were evaluated for incidence of apnea, pain on injection, jaw relaxation, conditions for LMA insertion, and complications such as muscle rigidity, hallucinations, and excessive secretions.
Induction time (time to reach BIS of 40) was faster in the KP group (150 ± 23.5 seconds) than in the P group (205 ± 37.4 seconds). The incidence of injection pain was significantly lower in the KP group (10%) than in the P group (80%). Excellent jaw relaxation and full mouth opening were higher in the KP group [45 patients (90%)] than in the P group [38 patients (76%)]. Excellent LMA insertion conditions were observed in 45 patients (90%) in the KP group and 38 patients (76%) in the P group. The KP group showed preserved hemodynamic stability (mean blood pressure, heart rate) with less incidence and duration of apnea compared to the P group.
ketofol is a safe and effective alternative induction agent for LMA insertion in children with rapid onset of action and lower incidence of injection pain. It provided better LMA insertion conditions, improved hemodynamic stability with less prolonged apnea when compared with propofol.
PMCID: PMC4173531
Bispectral index; hemodynamic; ketofol; LMA; propofol
20.  Clinical Accuracy and Safety Using the SynchroMed II Intrathecal Drug Infusion Pump 
Background and Objectives
We evaluated the infusion accuracy and device-related safety of implantable drug infusion pumps in subjects with chronic pain or severe spasticity.
Nine centers in the United States enrolled patients receiving intrathecal drug delivery systems to manage chronic pain and/or severe spasticity. Infusion accuracy was assessed at 6 and 12 months by comparing syringe-measured delivered volumes to programmer-predicted volumes. Safety was evaluated through analysis of adverse events. Separate laboratory testing conducted by the manufacturer also evaluated infusion accuracy.
Eighty of 82 enrolled subjects were implanted. Sixty-five and 54 subjects, respectively, were analyzable for accuracy at 6 and 12 months. On average at 6 months, the pumps were measured to have delivered 1% more than the programmed delivery volume. Analyzed on a per-refill basis, the pumps delivered, on average, 2.5% more than the programmed delivery volume. Differences between per-refill means versus per-subject cumulative means were due to limitations in clinicians’ ability to precisely visualize single small syringe-volume differences, or possibly incomplete withdrawal of fluid from the pump. Laboratory testing demonstrated a per-refill mean accuracy error of minus 2.4%. Because average observed flow-rate error at 6 and 12 months (1% overinfusion) was derived from pump residual volume measurements by syringe and carried out in a clinical setting, clinical volume ratios were larger than direct volume measurements by weight observed in the laboratory. No deaths, permanent injuries, or unanticipated adverse device effects occurred.
The pump accurately delivered intrathecal medication in the clinical setting of this study. Adverse events were similar in nature and severity to those described in the product labeling and literature.
PMCID: PMC4218763  PMID: 24956455
21.  A Hantavirus Pulmonary Syndrome (HPS) DNA Vaccine Delivered Using a Spring-powered Jet Injector Elicits a Potent Neutralizing Antibody Response in Rabbits and Nonhuman Primates  
Current Gene Therapy  2014;14(3):200-210.
Sin Nombre virus (SNV) and Andes virus (ANDV) cause most of the hantavirus pulmonary syndrome (HPS) cases in North and South America, respectively. The chances of a patient surviving HPS are only two in three. Previously, we demonstrated that SNV and ANDV DNA vaccines encoding the virus envelope glycoproteins elicit high-titer neutralizing antibodies in laboratory animals, and (for ANDV) in nonhuman primates (NHPs). In those studies, the vaccines were delivered by gene gun or muscle electroporation. Here, we tested whether a combined SNV/ANDV DNA vaccine (HPS DNA vaccine) could be delivered effectively using a disposable syringe jet injection (DSJI) system (PharmaJet, Inc). PharmaJet intramuscular (IM) and intradermal (ID) needle-free devices are FDA 510(k)-cleared, simple to use, and do not require electricity or pressurized gas. First, we tested the SNV DNA vaccine delivered by PharmaJet IM or ID devices in rabbits and NHPs. Both IM and ID devices produced high-titer anti-SNV neutralizing antibody responses in rabbits and NHPs. However, the ID device required at least two vaccinations in NHP to detect neutralizing antibodies in most animals, whereas all animals vaccinated once with the IM device seroconverted. Because the IM device was more effective in NHP, the Stratis® (PharmaJet IM device) was selected for follow-up studies. We evaluated the HPS DNA vaccine delivered using Stratis® and found that it produced high-titer anti-SNV and anti-ANDV neutralizing antibodies in rabbits (n=8/group) as measured by a classic plaque reduction neutralization test and a new pseudovirion neutralization assay. We were interested in determining if the differences between DSJI delivery (e.g., high-velocity liquid penetration through tissue) and other methods of vaccine injection, such as needle/syringe, might result in a more immunogenic DNA vaccine. To accomplish this, we compared the HPS DNA vaccine delivered by DSJI versus needle/syringe in NHPs (n=8/group). We found that both the anti-SNV and anti-ANDV neutralizing antibody titers were significantly higher (p-value 0.0115) in the DSJI-vaccinated groups than the needle/syringe group. For example, the anti-SNV and anti-ANDV PRNT50 geometric mean titers (GMTs) were 1,974 and 349 in the DSJI-vaccinated group versus 87 and 42 in the needle/syringe group. These data demonstrate, for the first time, that a spring-powered DSJI device is capable of effectively delivering a DNA vaccine to NHPs. Whether this HPS DNA vaccine, or any DNA vaccine, delivered by spring-powered DSJI will elicit a strong immune response in humans, requires clinical trials.
PMCID: PMC4161193  PMID: 24867065
DNA vaccine; hantavirus; jet injection.
22.  Diagnostics of hand-arm system disorders in workers who use vibrating tools. 
A hand-arm vibration syndrome occurs in some workers who use hand held vibrating tools. It is recognised to consist of white fingers, diffusely distributed finger neuropathy, pain in the arm and hand, and a small excess risk of osteoarthrosis from percussion to the wrist and elbow. Carpal tunnel syndrome is mainly due to ergonomic factors other than vibration, but certain factors related to vibration may contribute to its development. A decrease in muscle power induced by vibration, and excessive hearing deficit have been postulated. The assessment of a disorder suspected of being induced by vibration includes deciding whether there is a disorder and, if so, whether the symptoms can be caused by vibration. To decide whether the symptoms can be caused by vibration epidemiological documentation and pathogenically reasonable theories must exist. A causal diagnosis finally requires and epidemiological decision whether or not the factual exposure has elicited the patient's symptoms. Epidemiological data on the quantitative association between vibration and excessive risks of white fingers and diffusely distributed neuropathy are incomplete. The symptomatic diagnosis of white fingers is still mainly based on anamnestic information. Available laboratory tests are incapable of grading the severity of individual cases. Recording the finger systolic blood pressure during cold provocation is a method of symptomatic diagnosis with reasonable levels of specificity, sensitivity, and predictive value. For diffusely distributed neuropathy these levels are lower than desired. Electrodiagnostic tests for carpal tunnel syndrome have sufficient validity. Proper exposure evaluation must be based on an appreciation of the character of the vibration as well as effective duration and intermittency. If this is not taken into account, the number of hours of exposure and intensity of vibration are likely to be non-commensurable variables, and the simple product of them is a questionable dose measure. Separate models for risk evaluation of vascular and neurological disorders related to work with different tools and processes will have to be established. Ongoing research to obtain further data on exposure-response relations for neurological disturbances begins to yield encouraging results.
PMCID: PMC1128657  PMID: 9072015
23.  Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers 
A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe.
This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects’ preferred system for a final study injection or future treatment.
A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment.
This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.
PMCID: PMC2962403  PMID: 21049090
subcutaneous injection; autoinjector; self-injection; injection pain; preference; acceptance
24.  Prevalence of dental anxiety and its relation to age and gender in coastal Andhra (Visakhapatnam) population, India 
Dental fear, anxiety and phobia have consistently been reported as widespread problems that persist despite the technological advances that have made dentistry less painful and less uncomfortable. The aim of this study was to assess the prevalence of dental anxiety (DA) and its relation to age and sex among Coastal Andhra (Visakhapatnam) population.
Materials and Methods:
A randomized controlled study was designed among 340 individuals at GITAM Dental College and Hospital, Visakhapatnam. The sample for the study consisted of 180 female and 160 male subjects between 15 and 65 years of age; all were supplied with two questionnaires (Corah DA scale [CDAS] and Clarke and Rustvold dental concerns assessment scale describing anxiety provoking stimuli. The Mann-Whitney U-test and the Kruskal-Wallis test were applied (significance level P < 0.05). The correlations between the two questionnaires were calculated using the Spearman's rank correlation coefficient.
Two questionnaires were collected from all 340 individuals and the Indian translation of both instruments was found to be internally reliable with a Cronbach's alpha of 0.093. Overall prevalence of DA was high (77.4%) but severe (22.6%) anxiety (phobia) was low. Kruskal-Wallis test showed a significant relation between age and DA. The mean CDAS scores were high in 25-35 (11.08) and low in 55-65 (9.45) year age groups. Mann-Whitney U test showed significant relation between sex and DA. Mean CDAS score levels were significantly higher in females (10.88) than in males (9.96) (P < 0.0001).
Patients anxious about dental procedures are often more difficult to treat. If Dentists become aware about the level of DA among their patients, they can anticipate patient's behavior and can be prepared to take behavioral/pharmacological measures to reduce anxiety levels.
PMCID: PMC4121925  PMID: 25097425
Dental anxiety; dental anxiety scale; dental concerns assessment scale; dental fear; prevalence
25.  Delivery of low molecular weight heparin for prophylaxis against deep vein thrombosis using a novel, needle-less injection device (J-Tip). 
Given daily, low molecular weight (LMW) heparins are established for prophylaxis against deep vein thrombosis (DVT). We describe delivery by a novel, needle-less device that is virtually painless in action. Its use could provide benefits for patients in terms of comfort both psychologically and physically, and for healthcare workers in terms of safety from needle-stick injury. Patients undergoing elective surgery received LMW heparin delivered subcutaneously by either a standard needle and syringe or by the needle-less injection device, J-Tip. Pain was scored at the time of injection and plasma anti-factor Xa levels compared between the two methods of drug delivery 4 h later: 29 patients received LMW heparin delivered by the J-Tip and 31 patients by standard needle and syringe. The J-Tip was significantly more comfortable for the patient as the method of drug delivery (P < 0.001). When delivered by the J-Tip, LMW heparin was equally as efficacious, as plasma anti-factor Xa levels were similar for both methods of delivery (P < 0.42). In summary, delivery of LMW heparin by the J-Tip device was both comfortable and effective. These findings, taken in conjunction with its ease of use and complete freedom from risk of needle-stick injury might encourage further examination and use of this type of product.
PMCID: PMC2503472  PMID: 11103165

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