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author:("taddeo, Anna")
1.  Should an IRB Approve a Placebo-Controlled Randomized Trial of Analgesia for Procedural Pain in Neonates? 
Pediatrics  2012;130(3):550-553.
doi:10.1542/peds.2011-2910
PMCID: PMC4074620  PMID: 22891235
pain; placebo; research ethics; randomized trial
2.  Benchmarking pain outcomes for children with sickle cell disease hospitalized in a tertiary referral pediatric hospital 
BACKGROUND:
Painful vaso-occlusive crisis (VOC) is the most common reason for hospitalization in children with sickle cell disease.
OBJECTIVE:
To benchmark pain outcomes in sickle cell disease, including process outcomes (eg, pain assessment and documentation practices, pain management interventions) and clinical outcomes (eg, pain intensity over hospital stay), to identify areas for improvement.
METHODS:
A retrospective study was conducted on electronic charts of children hospitalized with a primary diagnosis of VOC between July 2007 and August 2008.
RESULTS:
A convenience sample of 50 admissions was used. In terms of clinical outcomes, patients presented to the emergency department with an initial median pain intensity of 9/10 (interquartile range 8/10 to 10/10). Forty-three per cent had not used opioids for pain relief at home. The mean (± SD) length of stay was 4.0±2.3 days. For most patients, median scores for highest daily pain intensity remained moderate to high throughout hospitalization, although scores did decrease significantly per day of hospitalization. In terms of process outcomes, pain intensity was assessed according to hospital standards on 25% of days in both the emergency department and the ward. There was no discrepancy between prescribed and administered opioid doses and medication use. In 95% of cases, strong opioid use was in a subtherapeutic or low therapeutic dosage range.
CONCLUSIONS:
The results showed three areas to target for improvement: improved pain assessment and documentation using valid pain tools; more aggressive multimodal management for peak VOC pain; and better education and support for pain management at home. Further studies are required to evaluate optimal pain treatment practices.
PMCID: PMC3411379  PMID: 22891195
Children; Pain assessment; Pain management; Sickle cell disease
3.  Improvements in pain outcomes in a Canadian pediatric teaching hospital following implementation of a multifaceted, knowledge translation initiative 
BACKGROUND:
A previous audit performed at a tertiary/quaternary pediatric hospital in Toronto, Ontario, demonstrated suboptimal assessment and treatment of children’s pain. Knowledge translation (KT) initiatives (education, reminders, audit and feedback) were implemented to address identified care gaps; however, the impact is unknown.
OBJECTIVES:
To determine the impact of KT initiatives on pain outcomes including process outcomes (eg, pain assessment and management practices) and clinical outcomes (eg, pain prevalence and intensity); and to benchmark additional pain practices, particularly opioid administration and painful procedures.
METHODS:
Medical records at The Hospital for Sick Children (Toronto, Ontario) were reviewed on a single day in September 2007. Pain assessment and management practices, and pain prevalence and intensity in the preceding 24 h were recorded on a standardized data collection form. Where possible, pain outcomes were compared with previous audit results.
RESULTS:
Records of 265 inpatients were audited. Sixty-three per cent of children underwent a documented pain assessment compared with 27% in an audit conducted previously (P<0.01). Eighty-three per cent of children with documented pain received at least one pain management intervention. Overall, 51% of children received pharmacological therapy, and 15% received either a psychological or physical pain-relieving intervention. Of those assessed, 44% experienced pain in the previous 24 h versus 66% in the previous audit (P<0.01). Fewer children experienced severe pain compared with the first audit (8.7% versus 26.1%; P<0.01). One-third of children received opioids; 19% of these had no recorded pain assessment. Among 131 children who underwent a painful procedure, 21% had a concurrent pain assessment. Painful procedures were accompanied by a pain-relieving intervention in 12.5% of cases.
CONCLUSIONS:
Following KT initiatives, significant improvements in pain processes (pain assessment documentation and pain management interventions) and clinical outcomes (pain prevalence, pain intensity) were observed. Further improvements are recommended, specifically with respect to procedural pain practices and opioid utilization patterns.
PMCID: PMC3401088  PMID: 22606682
Knowledge translation; Pain assessment; Pain intensity; Pain management; Pain prevalence; Painful procedures
4.  Knowledge translation of the HELPinKIDS clinical practice guideline for managing childhood vaccination pain: usability and knowledge uptake of educational materials directed to new parents 
BMC Pediatrics  2013;13:23.
Background
Although numerous evidence-based and feasible interventions are available to treat pain from childhood vaccine injections, evidence indicates that children are not benefitting from this knowledge. Unrelieved vaccination pain puts children at risk for significant long-term harms including the development of needle fears and subsequent health care avoidance behaviours. Parents report that while they want to mitigate vaccination pain in their children, they lack knowledge about how to do so. An evidence-based clinical practice guideline for managing vaccination pain was recently developed in order to address this knowledge-to-care gap. Educational tools (pamphlet and video) for parents were included to facilitate knowledge transfer at the point of care. The objectives of this study were to evaluate usability and effectiveness in terms of knowledge acquisition from the pamphlet and video in parents of newly born infants.
Methods
Mixed methods design. Following heuristic usability evaluation of the pamphlet and video, parents of newborn infants reviewed revised versions of both tools and participated in individual and group interviews and individual knowledge testing. The knowledge test comprised of 10 true/false questions about the effectiveness of various pain management interventions, and was administered at three time points: at baseline, after review of the pamphlet, and after review of the video.
Results
Three overarching themes were identified from the interviews regarding usability of these educational tools: receptivity to learning, accessibility to information, and validity of information. Parents’ performance on the knowledge test improved (p≤0.001) from the baseline phase to after review of the pamphlet, and again from the pamphlet review phase to after review of the video.
Conclusions
Using a robust testing process, we demonstrated usability and conceptual knowledge acquisition from a parent-directed educational pamphlet and video about management of vaccination pain. Future studies are planned to determine the impact of these educational tools when introduced in clinical settings on parent behaviors during infant vaccinations.
doi:10.1186/1471-2431-13-23
PMCID: PMC3585914  PMID: 23394070
Vaccination; Pain management; Infant/child; Health information; Knowledge translation; Implementation; Parent education
5.  Practices and perceptions regarding pain and pain management during routine childhood immunizations: Findings from a focus-group study with nurses working at Toronto Public Health, Ontario 
INTRODUCTION:
Despite the availability of a variety of evidence-based interventions, it has previously been reported that the majority of infants and children undergo vaccine injections without the benefit of analgesia. Nurses in public health administer a substantial number of injections; however, their attitudes and practices surrounding acute pain during vaccine injections have not been previously explored.
METHODS:
A focus-group interview was conducted in Toronto, Ontario, with 10 nurses who immunize children. Participants reported their perceptions and practices with regard to vaccine injection pain and pain management.
RESULTS:
Three key themes emerged: environmental and process factors, perceptions regarding the effectiveness of different analgesic interventions, and perceptions regarding pain and fear. Participants reported a lack of control over their environment, resulting in fear and discomfort for children. They recommended increased support from external partners such as school teachers and administrators. Participants reported that pharmacological interventions, such as topical local anesthetics, were not used; however, psychological and physical interventions were commonly used. Nurses questioned the effectiveness of topical anesthetics, and indicated that more education was required regarding effective analgesic interventions. Needle pain was reported to be the most prominent concern for children undergoing vaccine injections, and children were described as being fearful.
DISCUSSION:
Nurses reported vaccination setting, analgesic effectiveness and relative importance given to pain as important factors for pain and pain management during vaccine injections. Future studies should explore whether additional perspectives are present in vaccinators in other geographical regions. The effectiveness of educational resources and pain management programs aimed at improving current practices should be investigated.
PMCID: PMC3142592  PMID: 22654924
Immunization; Infants/children nurses; Pain management
8.  Mothers’ beliefs about analgesia during childhood immunization 
Paediatrics & Child Health  2010;15(5):289-293.
BACKGROUND:
Immunization injections are the most common painful medical procedures experienced during childhood, yet there is a discrepancy between recommendations for the effective use of topical anesthetics to reduce vaccine injection pain and actual practice.
OBJECTIVE:
To improve our understanding of mothers’ experiences and practices regarding their children’s routine immunizations.
METHOD:
Adopting an interpretive, naturalistic paradigm, semi-structured interviews were conducted with 15 mothers to examine their perceptions and experiences of their children’s immunization pain and pain management.
RESULTS:
The findings demonstrated three main themes: attitudes toward immunization pain, immunization pain management and physicians as sources of information. Participants described feeling distressed while their children were being immunized, but most managed these difficulties by focusing on the benefits of immunization and by minimizing or justifying the pain. All of the participants used non-pharmacological techniques to manage immunization injection pain. Few mothers were aware of the availability of topical anesthetics. When participants did use pharmacological analgesic approaches, oral analgesics were most likely to be used for prophylaxis and treatment of fever, and participants were unaware of evidence-based approaches to managing pain. Participants viewed their physicians as trusted sources of information, and the majority said that they would likely use a topical anesthetic in the future if recommended or approved by their physician.
CONCLUSION:
The present findings provide direction for future knowledge translation activities to enhance the knowledge of mothers and clinicians regarding pain during immunization injections and its effective management.
PMCID: PMC2912630  PMID: 21532793
Child; Immunization; Infant; Pain management; Qualitative research; Topical anesthetics
9.  Epidemiology and management of painful procedures in children in Canadian hospitals 
Background
Children being cared for in hospital undergo multiple painful procedures daily. However, little is known about the frequency of these procedures and associated interventions to manage the pain. We undertook this study to determine, for children in Canadian hospitals, the frequency of painful procedures, the types of pain management interventions associated with painful procedures and the influence of the type of hospital unit on procedural pain management.
Methods
We reviewed medical charts for infants and children up to 18 years of age who had been admitted to 32 inpatient units at eight Canadian pediatric hospitals between October 2007 and April 2008. We recorded all of the painful procedures performed and the pain management interventions that had been implemented in the 24-hour period preceding data collection. We performed descriptive and comparative (analysis of variance, χ2) analyses.
Results
Of the 3822 children included in the study, 2987 (78.2%) had undergone at least one painful procedure in the 24-hour period preceding data collection, for a total of 18 929 painful procedures (mean 6.3 per child who had any painful procedure). For 2334 (78.1%) of the 2987 children who had a painful procedure, a pain management intervention in the previous 24 hours was documented in the chart: 1980 (84.8%) had a pharmacologic intervention, 609 (26.1%) a physical intervention, 584 (25.0%) a psychologic intervention and 753 (32.3%) a combination of interventions. However, for only 844 (28.3%) of the 2987 children was one or more pain management interventions administered and documented specifically for a painful procedure. Pediatric intensive care units reported the highest proportion of painful procedures and analgesics administered.
Interpretation
For less than one-third of painful procedures was there documentation of one or more specific pain management interventions. Strategies for implementing changes in pain management must be tailored to the type of hospital unit.
doi:10.1503/cmaj.101341
PMCID: PMC3080557  PMID: 21464171
10.  Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial 
Background
Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. A pilot clinical trial to determine the feasibility of an RCT was conducted and is reported here.
Methods
12 participants 12 to 35 years old were recruited to a prospective open-label pilot trial and treated with 60 mg of standardized G. biloba two times per day for 12 weeks. The criteria for feasibility included successful recruitment, 75% or greater retention, effectiveness and lack of serious adverse reactions. Effectiveness was assessed using the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF), which are validated outcome measures evaluating the area and intensity of depigmentation of vitiligo lesions. Other outcomes included photographs and adverse reactions. Safety was assessed by serum coagulation factors (platelets, PTT, INR) at baseline and week 12.
Results
After 2 months of recruitment, the eligible upper age limit was raised from 18 to 35 years of age in order to facilitate recruitment of the required sample size. Eleven participants completed the trial with 85% or greater adherence to the protocol. The total VASI score improved by 0.5 (P = 0.021) from 5.0 to 4.5, range of scale 0 (no depigmentation) to 100 (completely depigmented). The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. VETF total vitiligo lesion area decreased 0.4% (P = 0.102) from 5.9 to 5.6 from baseline to week 12. VETF staging score improved by 0.7 (P = 0.101) from 6.6 to 5.8, and the VETF spreading score improved by 3.9 (P < 0.001)) from 2.7 to -1.2. There were no statistically significant changes in platelet count, PTT, or INR.
Conclusions
The criteria for feasibility were met after increasing the maximum age limit of the successful recruitment criterion; participant retention, safety and effectiveness criteria were also met. Ingestion of 60 mg of Ginkgo biloba BID was associated with a significant improvement in total VASI vitiligo measures and VETF spread, and a trend towards improvement on VETF measures of vitiligo lesion area and staging. Larger, randomized double-blind clinical studies are warranted and appear feasible.
Trial Registration
Clinical trials.gov registration number NCT00907062
doi:10.1186/1472-6882-11-21
PMCID: PMC3065445  PMID: 21406109
11.  The effect of distant reiki on pain in women after elective Caesarean section: a double-blinded randomised controlled trial 
BMJ Open  2011;1(1):e000021.
Introduction
Approximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer healing energy through light touch and positive healing intention. Although 1.2 million Americans use reiki to reduce pain or depression, there is a lack of strong evidence supporting its effectiveness. A recent systematic review showed existing studies to be of poor methodological quality, with the common limitation of lack of blinding. To overcome this issue, the authors used distant reiki to assess its effectiveness in reducing pain following an elective C-section.
Methods
In this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1–3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs.
Results
AUC for pain was not significantly different in the distant reiki and control groups (mean±SD; 212.1±104.7 vs 223.1±117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3±8.1 bpm vs 79.8±7.9 bpm, p=0.003) and blood pressure (106.4±9.7 mm Hg vs 111.9±11.0 mm Hg, p=0.02) post surgery.
Conclusion
Distant reiki had no significant effect on pain following an elective C-section.
Clinical Trial Registration Number
ISRCTN79265996.
Article summary
Article focus
This is the first randomised, double-blinded trial conducted on distant reiki.
The focus in on distant reiki's effects on pain after Caesarean section.
Special attention was paid to the methods of proper randomisation, patient allocation concealment and blinding.
Key messages
Our trial suggests that distant reiki had no benefit in reducing patients' postpartum pain over usual care for elective Caesarean section.
Strengths and limitations of this study
We engaged a highly experienced reiki master to administer distant reiki removing the placebo effect which was present in all other pain trials. In addition, we maintained a high adherence to protocol, successful blinding of the research team, successful randomisation and patient allocation concealment, and diligent data collection with extremely few data points missed. We had good credibility with research participants, as all but 10 women refused to participate. We evaluated other aspects of healing after elective Caesarean section, beyond patients' perceived pain levels, by including the previously developed and published Milestone Questionnaire.
A potential limitation was the magnitude of pain on which we were attempting to show an impact. Just as acetaminophen is not suitable as pain medication after Caesarean section, distant reiki may also not be suitable for this magnitude of pain. In addition, since some patients were discharged early, our complete dataset is limited to 48 h, with gaps in data for 16 patients (20%) accounted for by carrying the last pain score forward. To ensure that this method did not distort the results, we also evaluated AUC for pain on day 1 and day 2 individually and found no differences between groups for both these time periods.
doi:10.1136/bmjopen-2010-000021
PMCID: PMC3191394  PMID: 22021729
Pain; surgery; reiki; CAM; C-section; pain management; surgery; complementary medicine; obstetrics and gynaecology
12.  Vaccine‐related pain: randomised controlled trial of two injection techniques 
Archives of Disease in Childhood  2007;92(12):1105-1108.
Objective
To compare acute pain response during immunisation in infants using a slow standard of care injection technique versus a rapid pragmatic technique.
Design
Randomised controlled trial.
Setting
Single‐centre, urban paediatric primary care practice.
Subjects
Healthy infants 4–6 months of age receiving their routine DPTaP‐Hib immunisation.
Interventions
Standard of care group: slow aspiration prior to injection, slow injection and slow withdrawal. Pragmatic group: no aspiration, rapid injection and rapid withdrawal.
Main outcome measures
Immediate infant pain measured by the Modified Behavior Pain Scale (MBPS), crying and parent/paediatrician visual analogue scale (VAS).
Results
113 infants participated; there were no observed differences in age, birth order or prior analgesic use. Mean MBPS scores (95% confidence interval (CI)) were higher (p<0.001) for the standard group compared to the pragmatic group, 5.6 (5 to 6.3) vs 3.3 (2.6 to 3.9). The standard group was more likely to cry, 47/57 (82%) vs 24/56 (43%), to cry longer, median (interquartile range (IQR)) 14.7 s (8.7–35.6) vs 0 s (0–11.30), and to take longer to have the vaccine injected, median (IQR) 8.8 s (7.9–10.3) vs 0.9 s (0.8–1.1), p<0.001 for all comparisons. The median (IQR) VAS scores by parents and paediatricians were higher for the standard group: VAS parent, 3.5 (1.6–5.5) vs 1.9 (0.1–3.1) and VAS paediatrician, 2.8 (2.0–5.1) vs 1.4 (0.2–2.4). There were no adverse events.
Conclusion
Immunisation using a pragmatic rapid injection technique is less painful than a slow standard of care technique and should be recommended for routine intramuscular immunisations.
doi:10.1136/adc.2007.118695
PMCID: PMC2066084  PMID: 17686797
needle aspiration; injection speed; immunisation; pain
13.  Effectiveness of sucrose analgesia in newborns undergoing painful medical procedures 
Background
Sucrose is widely used to manage procedural pain in term newborns despite a lack of evidence of its effectiveness for different procedures and infant populations. Our objectives were to evaluate the effectiveness and safety of sucrose in newborns undergoing various medical procedures within 2 days of birth.
Methods
We performed a double-blind, randomized controlled trial. We included newborns (≥ 36 weeks gestation) of diabetic mothers and nondiabetic mothers. Each newborn received 2 mL of a 24%-sucrose or placebo solution before all procedures. We used the Premature Infant Pain Profile to assess pain during intramuscular injection of vitamin K, venipuncture for the newborn screening test and the first 3 heel lances for glucose monitoring (newborns of diabetic mothers only). Scores ranged from from 0 (no pain) to 18 (maximum pain).
Results
We included 240 newborns (120 from diabetic mothers, 120 from nondiabetic mothers). The overall mean pain score was lower among newborns who received sucrose than among those who received a placebo (mean difference –1.3, 95% confidence interval [CI] –2.0 to –0.6). We found that pain scores during intramuscular injection did not differ significantly between the sucrose and placebo groups for newborns of diabetic or nondiabetic mothers (newborns of nondiabetic mothers: mean difference –1.1, 95% CI –2.4 to 0.2; newborns of diabetic mothers: mean difference –1.0, 95% CI –2.4 to 0.4). During venipuncture, newborns who received sucrose had lower pain scores compared with those who received a placebo (newborns of nondiabetic mothers: mean difference –3.2, 95% CI –4.6 to –1.8; newborns of diabetic mothers: mean difference –2.4, 95% CI –3.8 to –1.0). Among newborns of diabetic mothers, there was no difference in pain during the first 3 heel lances or mean glucose levels between the sucrose and placebo groups (p = 0.94 and p = 0.29 respectively).
Interpretation
We found a modest reduction of pain in newborns of both diabetic and nondiabetic mothers when sucrose was used for all medical procedures performed in the first 2 days after birth. However, when each procedure was analyzed separately, we found that the effectiveness of sucrose was limited to venipuncture for the newborn screening test. (http://Clinicaltrials.gov trial register no. NCT00213213.)
doi:10.1503/cmaj.071734
PMCID: PMC2464480  PMID: 18591525
14.  Effect of iron content on the tolerability of prenatal multivitamins in pregnancy 
Background
Gastrointestinal irritability can deter pregnant women from starting or continuing prenatal multivitamin supplementation. In a previous study, suboptimal tolerability was observed among pregnant women taking a large tablet (18 mm × 8 mm × 8 mm) multivitamin with high elemental iron content (60 mg as ferrous fumarate). The objective of the present study was to compare rates of adherence and reported adverse events among pregnant women who were randomized to commence supplementation with a small-tablet prenatal multivitamin, containing either low or high iron content.
Methods
Pregnant women who called the Motherisk Program (Hospital for Sick Children, Toronto) and had not started taking or had discontinued any multivitamin due to adverse events were included in this prospective, randomized, open-label, 2-arm study. Women were randomized to take a small-size (16 mm × 9 mm × 4 mm), low elemental iron content (35 mg as ferrous fumarate) multivitamin ('35 mg' group); or a small-size (5 mm radius, 5 mm thickness), high elemental iron content (60 mg as ferrous sulphate) multivitamin ('60 mg' group). Follow-up interviews documented pill intake and adverse events. Rates of adherence and adverse events were compared between groups using chi-squared tests and Kaplan-Meier survival curves.
Results
Of 167 randomized women, 92 in the '35 mg' group and 75 in the '60 mg' group were included in the analysis. Despite ideal conditions and regular follow-ups, mean adherence based on pill intake recall, in both groups was approximately 50%. No statistically significant difference was detected in proportions of women who actually started taking either multivitamin. Among those who started, no difference was detected in rates of adherence or reported adverse events.
Conclusion
The present results suggest that iron content is not a major determinant of adherence to prenatal multivitamins. Combined with our previous study, tablet size may be the more definitive factor affecting adherence.
doi:10.1186/1471-2393-8-17
PMCID: PMC2405769  PMID: 18482454
15.  Reducing procedural pain 
doi:10.1503/cmaj.1050226
PMCID: PMC1329466
16.  Liposomal lidocaine to improve procedural success rates and reduce procedural pain among children: a randomized controlled trial 
Background
Historically, children have been undertreated for their pain, and they continue to undergo painful cutaneous procedures without analgesics. A new topical anesthetic, liposomal lidocaine 4% cream (Maxilene, RGR Pharma, Windsor, Ont.), has become available. It has pharmacologic properties that are superior to other topical anesthetics, including an onset of action of only 30 minutes. We sought to determine the success rate of cannulation, analgesic effectiveness, procedure duration and rate of adverse skin reactions when liposomal lidocaine is used before intravenous cannulation of children.
Methods
In this double-blind randomized controlled trial, children aged 1 month to 17 years received liposomal lidocaine or placebo before cannulation. Success on first cannulation attempt was recorded, and, among children 5 years and older, pain was evaluated before and after the attempt by the child, parents and research assistant using a validated measure (Faces Pain Scale-Revised). For children younger than 5 years, pain was evaluated by the parents and research assistant only. The total duration of the procedure and adverse skin reactions were also recorded.
Results
Baseline characteristics did not differ (p > 0.05) between children who received liposomal lidocaine (n = 69) and those who received placebo (n = 73). Cannulation on the first attempt was achieved in 74% of children who received liposomal lidocaine compared with 55% of those who received placebo (p = 0.03). Among children 5 years of age and older (n = 67), lower mean pain scores during cannulation were reported by those receiving liposomal lidocaine (p = 0.01). Similarly, lower mean pain scores during cannulation were reported by the parents and research assistant for all children who received liposomal lidocaine than for all those who received placebo (p < 0.001). The mean total procedure duration was shorter with liposomal lidocaine (6.7 v. 8.5 minutes; p = 0.04). The incidence of transient dermal changes was 23% in both groups (p = 1.0).
Conclusions
Use of liposomal lidocaine was associated with a higher intravenous cannulation success rate, less pain, shorter total procedure time and minor dermal changes among children undergoing cannulation. Its routine use for painful cutaneous procedures should be considered whenever feasible.
doi:10.1503/cmaj.045316
PMCID: PMC1150261  PMID: 15967972

Results 1-16 (16)