To evaluate the short- and long-term results of laparoscopic enterolysis in patients with chronic pelvic pain following hysterectomy.
Forty-eight patients were evaluated at time intervals from 2 weeks to 5 years after laparoscopic enterolysis. Patients were asked to rate postoperative relief of their pelvic pain as complete/near complete relief (80-100% pain relief), significant relief (50-80% pain relief), or less than 50% or no pain relief.
We found that after 2 to 8 weeks, 39% of patients reported complete/near complete pain relief, 33% reported significant pain relief, and 28% reported less than 50% or no pain relief. Six months to one year postlaparoscopy, 49% of patients reported complete/near complete pain relief, 15% reported significant pain relief, and 36% reported less than 50% or no pain relief. Two to five years after laparoscopic enterolysis, 37% of patients reported complete/near complete pain relief, 30% reported significant pain relief, and 33% reported less than 50% or no pain relief. Some patients required between 1 and 3 subsequent laparoscopic adhesiolysis. A total of 3 enterotomies and 2 cystotomies occurred, all of which were repaired laparoscopically.
We conclude that laparoscopic enterolysis may offer significant long-term relief of chronic pelvic pain in some patients.
Laparoscopy; Adhesiolysis; Pain relief; Complications
Sixty-one laparoscopic presacral neurectomies were performed in Chang Gung Memorial Hospital, Keelung Center over a 1-year period for patients with primary dysmenorrhea who failed to respond
to medical management. Eighty-three percent (50) had complete relief of pain, 10% (6) had significant relief, 3.5% (2) had moderate relief, and 3.5% (2) had no relief from their dysmenorrhea at their first menstruation after the procedure. One vascular complication requiring laparotomy occurred. Average total operation time was 24 minutes, and the average hospital stay was 2 days. Six months
follow-up was done in 35 patients with complete symptom relief, and all reported continued relief
of menstrual pain. The efficacy of laparoscopic presacral neurectomy for the pain relief of primary
dysmenorrhea is justified in this report.
The purpose of this study was to assess the attitudes of maternal health care providers to pain relief during labor in Zaria, Nigeria.
This was a multicenter, collaborative, cross-sectional pilot study of provider perspectives concerning pain relief during labor. A structured, self-administered, questionnaire was completed by 95 consenting maternal health care providers at three high-volume facilities in Zaria, an ancient northern Nigerian city. Descriptive statistics was performed on the data.
Most respondents (94.8%) agreed that pain relief is needed during labor. Only 2.1% of respondents were undecided about the provision of pain relief during labor and 3.2% were of the opinion that pain relief was not necessary during labor. Most respondents (93.7%) had attended a woman in labor in the 4 weeks preceding the survey. Of these, 56.8% had counseled a parturient in labor. Most of the counseling (42.1%) took place during labor. Less than half of the respondents (48.4%) had administered pain relief in labor in the preceding 4 weeks and systemic opioids was the most commonly form of pain relief. Among the respondents who did not offer pain relief agents in labor, the majority (54.5%) had no reason for not offering it. Unavailability of methods, inability to afford the cost of pain relief, lack of knowledge and skills, as well as lack of essential equipment to provide the procedure were also given by respondents as reasons for not offering pain relief.
Even though maternal health care providers in this environment have a positive attitude to pain relief in labor, most women go through labor without the benefit of analgesia. There exists a gap between provider attitudes to pain relief in labor and practice of the same, with many providers having no genuine reason(s) for not offering pain relief to their clients during labor. Providers need to align their practice to their attitudes, and need to be helped to do this through training as well as enhancing their ability to think critically about their practice.
pain relief; providers; attitudes; practice; labor; conflict
Breakthrough pain, a transitory severe pain with the background of otherwise controlled persistent pain has a prevalence between 52% and 67% in outpatients with cancer. Medications for such sudden-onset pain require non-invasive delivery of a potent and short-acting opioid for rapid pain relief. Although oral transmucosal delivery of fentanyl citrate (OTFC) has been shown to provide better pain relief than a typical oral opioid administration such as morphine sulfate immediate release (MSIR) in the management of breakthrough pain in patients with cancer-related pain, newer delivery systems offer a potential for further enhancement of pain relief. The fentanyl effervescent buccal tablet (FBT) formulation employs a novel drug delivery system that relies on an effervescence reaction to improve buccal fentanyl absorption. Using the effervescence reaction results in the production and dissipation of carbon dioxide with a dynamic shift in pH as the tablet dissolves. The induced low pH favors dissolution of fentanyl citrate in saliva (higher water solubility). The subsequent increase in pH thereafter favors the buccal absorption of non-ionized fentanyl across the buccal mucosa. Such a pH “pumping” mechanism increases the permeation of fentanyl into and through the buccal to the vascular system from where the agent is transported to the specific opioid receptor sites in the CNS. Compared with OTFC, data in healthy volunteers show that the effervescence reaction employed in FBT increases the total amount and the speed of absorption of fentanyl being absorbed. Compared with OTFC there is an increase in peak fentanyl blood concentrations, and an enhancement of the amount of buccal delivery of fentanyl. Such favorable data are underlined by the results of clinical studies where the FBT technology was studied in patients with breakthrough pain in chronic malignant pathologies.
breakthrough pain; fentanyl effervescent buccal tablet (FBT); cancer pain; effervescent technology
When moderate pain was presented in a context of intense pain, it induced a relief and ‘hedonic flip’ such that pain was reported as pleasant.
Context can influence the experience of any event. For instance, the thought that “it could be worse” can improve feelings towards a present misfortune. In this study we measured hedonic feelings, skin conductance, and brain activation patterns in 16 healthy volunteers who experienced moderate pain in two different contexts. In the “relative relief context,” moderate pain represented the best outcome, since the alternative outcome was intense pain. However, in the control context, moderate pain represented the worst outcome and elicited negative hedonic feelings. The context manipulation resulted in a “hedonic flip,” such that moderate pain elicited positive hedonics in the relative relief context. Somewhat surprisingly, moderate pain was even rated as pleasant in this context, despite being reported as painful in the control context. This “hedonic flip” was corroborated by physiological and functional neuroimaging data. When moderate pain was perceived as pleasant, skin conductance and activity in insula and dorsal anterior cingulate were significantly attenuated relative to the control moderate stimulus. “Pleasant pain” also increased activity in reward and valuation circuitry, including the medial orbitofrontal and ventromedial prefrontal cortices. Furthermore, the change in outcome hedonics correlated with activity in the periacqueductal grey (PAG) of the descending pain modulatory system (DPMS). The context manipulation also significantly increased functional connectivity between reward circuitry and the PAG, consistent with a functional change of the DPMS due to the altered motivational state. The findings of this study point to a role for brainstem and reward circuitry in a context-induced “hedonic flip” of pain.
Reward; Neuroimaging; Dread; Relief; Value
OBJECTIVE: To compare pre-hospital parental administration of pain relief for children with that of the accident and emergency (A&E) department staff and to ascertain the reason why pre-hospital analgesia is not being given. DESIGN/METHODS: An anonymous prospective questionnaire was given to parents/guardians of children < 17 years. The children were all self referred with head injuries or limb problems including burns. The first part asked for details of pain relief before attendance in the A&E department. The second part of the questionnaire contained a section for the examining doctor and triage nurse to fill in. The duration of the survey was 28 days. RESULTS: Altogether 203 of 276 (74%) of children did not receive pain relief before attendance at the A&E department. Reasons for parents not giving pain relief included 57/203 (28%) who thought that giving painkillers would be harmful; 43/203 (21%) who did not give painkillers because the accident did not happen at home; and 15/203 (7%) who thought analgesia was the responsibility of the hospital. Eighty eight of the 276 (32%) did not have any painkillers, suitable for children, at home. A&E staff administered pain relief in 189/276 (68%). CONCLUSIONS: Parents often do not give their children pain relief before attending the A&E department. Parents think that giving painkillers may be harmful and often do not have simple analgesics at home. Some parents do not perceive that their child is in pain. Parents require education about appropriate pre-hospital pain relief for their children.
Admission to clinical trials is often based on the assumption of homogeneity of the population. A group of 60 patients, all with pain in the neck or shoulder of at least 3 months duration, were studied. Expectation was graded before treatments were started by sharing out 100 points between freedom from side effects, pain relief, depression relief, improved mobility, improved sleep and speed of action. A double-blind crossover study of two established anti-inflammatory analgesics and placebo was carried out. Using analogue scales, patients were asked to grade their response. Side effects were recorded, and preference was established at the end of the study.
Although all the patients were in sufficient pain to require medical attention, some rated relief of depression, improvement in sleep or lack of side effects as more important than pain relief. Differences between drug and placebo were most clearly demonstrated in those patients whose main concern was improved mobility. In our view it is important to select patients who are in need of a dominant property of a drug for a trial of this property and this may have ramifications across the medical spectrum.
The treatment of pain in acute myocardial infarction varies with local practice. Narcotic analgesics are still the usual treatment in many hospitals. Knowledge of optimal doses, duration of pain relief, and time between drug administration and pain relief is inadequate. Many studies indicate that the relief of pain is often incomplete after treatment with narcotic analgesics. There is often a need for alternative treatments. Large randomised studies consistently show that beta blockade, initially given intravenously and then orally, relieves pain and reduces the need for analgesics. Studies also indicate that early administration of streptokinase and glyceryl trinitrate relieves pain. There is evidence that drugs that limit ischaemic damage also relieve pain.
Six different pain rating scales, including a "pain relief scale", were compared in 80 patients suffering acute orofacial pain. Pain intensity measurements were made before and after a 30 min period of afferent stimulation (TENS/vibration and placebo). A good correlation was found between pain scores derived from the pain relief scale, visual analogue-, numerical- and graphic rating scales. The verbal rating scale did not perform well. The pain relief scale and the numerical rating scale are interesting alternatives to the established visual analogue scale.
To analyze long-term clinical results of coagulation lesions of the dorsal root entry zone (DREZ) in patients with deafferentation pain due to brachial plexus avulsion and to correlate the pain relief after DREZ coagulation with pain duration before the DREZ coagulation.
Twenty-six patients with intractable deafferentation pain after brachial plexus avulsion lesion were treated for pain at the Department of Neurosurgery. Junctional coagulation lesion was made with bipolar forceps along the DREZ. The patients assessed post-operative analgesic effect using a visual analog scale at 1 week, 1 year, 3 years, and 5 years after the surgery.
The greatest pain relief was reported immediately after the DREZ procedure. Over the 5-year follow-up period, the pain relief effect gradually and significantly decreased. There were no significant differences between the pain relief evaluated at 1 week and after 1 year and between the pain relief evaluated at 1 week and after 3 years. There was a correlation between the pain duration before the surgery and pain relief after the surgery, with best correlation found between pain duration before surgery and pain relief 5 years after DREZ procedure (r = 0.623, P = 0.007).
The long-term follow up showed that the pain relief gradually decreased over 5 years after surgery. However, the pain relief still did not significantly decrease after 3 years.
Pain control following painful orthopaedic procedures such as total knee arthroplasty (TKA) is an ongoing challenge, as current pain management techniques often result in under-medication and/or complications. In a study designed to test the effect of the micro-current skin patch (MCT) on pain relief in patients following TKA, we followed 24 patients, randomly divided into two groups, one group receiving MCT plus tramadol hydrochloride (tramadol) for pain relief and a control group receiving only tramadol, for 10 days postoperatively. Tramadol was given intramuscularly in increment doses of 100 mg, as needed, for the duration of the study period. Pain was assessed daily using a visual analogue score (VAS). Other parameters, including the effect of MCT on the dose of tramadol needed for pain relief, the degree of wound healing measured at the end of the follow-up period, category of the wound 10 days postoperatively (1, 2 or 3) and total drain fluid volume, were also assessed. During the 10-day postoperative period there was a progressive decrease in pain in patients of both groups, however the patients of the MCT group showed a consistently lower VAS throughout the observation period, most markedly on those follow-up days with the highest pain scores in patients of the control group. This effect was monitored on the basis of the average dose of tramadol administered per day: 200.0±7.0 mg/day in the control group and 63.3±15.8 mg/day in the MCT group. Wound healing was better with the application of the MCT patch: grade 1 wounds were observed in 50% of the patients of the MCT group as compared to 8.3% in control group. The total drain volume was lower in patients of the MCT group compared to the controls (1020.8±211.6 and 1170.8±243.5 ml, respectively). None of the patients indicated that they wished to discontinue MCT therapy. This pilot study shows that MCT therapy led to better pain control with a markedly lower need for tramadol as compared to the control group. This better pain control was accompanied by a better healing of the wound and a lower drain volume.
Pain is aversive, but does the cessation of pain (‘relief’) have a reward-like effect? Indeed, fruitflies avoid an odour previously presented before a painful event, but approach an odour previously presented after a painful event. Thus, event-timing may turn punishment to reward. However, is event-timing also crucial in humans who can have explicit cognitions about associations? Here, we show that stimuli associated with pain-relief acquire positive implicit valence but are explicitly rated as aversive. Specifically, the startle response, an evolutionarily conserved defence reflex, is attenuated by stimuli that had previously followed a painful event, indicating implicit positive valence of the conditioned stimulus; nevertheless, participants explicitly evaluate these stimuli as ‘emotionally negative’. These results demonstrate a rift between the implicit and explicit conditioned valence induced by pain relief. They might explain why humans in some cases are attracted by conditioned stimuli despite explicitly judging them as negative.
relief; pain; startle reflex
The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.
The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.
The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.
This study is registered at ClinicalTrials.gov., NCT01200277.
There is the need to adequately inform patients about their disease, treatment options, surgery and post-operative complications. Adequate pain relief after surgery leads to less morbidity. Two important aspects of surgical practice are being addressed in this paper, the need for informed consent and post operative pain relief.
A questionnaire survey was carried out in 100 patients on the four general surgical wards of the Korle Bu Teaching Hospital, just before they were discharged from hospital. They were asked what they knew or had been informed about their diagnosis, operation and complications of surgery. On pain relief, patients were asked about their experiences on the first post-operative day and what relief they had from analgesics.
Twenty four did not know the diagnosis and 36 were not told what operation they were going to have before surgery. Although 75 were eventually told what operation they had, only 64 said they knew the operation. Sixty eight did not know what to expect after surgery; 87 did not know about possible complications. On the first post-operative day there was significant pain (scores 4 and 5) felt by 24 patients at rest and 46 on movement. The most frequently prescribed analgesic was pethidine.
Patient information in General surgery at the Korle Bu Teaching Hospital is unsatisfactory. Post-operative analgesia is also poor. There is the need for surgeons to either train doctors to administer consent or administer it themselves. Anaesthetists should assume a leading role in managing post-operative pain.
Consent; post-operative analgesia; patient information; complications; surgery; Korle Bu
Nearly one million cancer patients in India need oral morphine for pain relief. Despite doctors prescribing oral morphine in our center, many cancer patients with severe pain found to be not facilitated with adequate pain relief.
This audit was conducted to look at the “oral morphine prescribing practices for severe cancer pain” at a tertiary care hospital.
Materials and Methods:
Twenty case files of patients, who were admitted with severe cancer pain, and receiving oral morphine were analyzed in pre- and posteducational session. Local standards were set to assess the adequacy of pain relief. Deficiency in achieving analgesia was found in preinterventional audit. A clinical audit was conducted before and after the educational session on oral morphine prescribing. The education for doctors and nurses focused on starting patients on morphine, titration, and administering rescue dose. Then local guidelines on oral morphine prescribing were circulated. And analysis of following factors were done following pre- and posteducational session: Pain intensity at the beginning of treatment, starting dose of morphine, increments in morphine dose, number of rescue doses given, and fall in pain intensity at the end of 1 week. The outcomes were compared with the standards.
Preintervention audit showed that only 50% of patients achieved adequate pain relief. Rescue dose was administered in only 20% of patients. While reaudit following the educational session showed that 80% of patients achieved adequate pain relief and 100% received rescue doses.
Educational sessions have significant impact on improving oral morphine prescribing practice among doctors and nurses. It was found failing to administer regular as well as rescue doses resulted in inadequate pain relief in patients receiving oral morphine.
Cancer pain; Oral morphine; Pain relief; Prescribing practices
To determine the degree and duration of pain relief provided by specific pain treatments used by individuals with spinal cord injury (SCI) who have chronic pain.
Participants were 117 individuals who had traumatic SCI, were 18 years of age or older, and reported a chronic pain problem.
Main Outcome Measures:
Questions assessing current or past use of 26 different pain treatments, the amount of relief each treatment provided, and the length of time that any pain relief usually lasts.
The medications tried most often were nonsteroidal anti-inflammatory drugs (tried by 71%) and acetaminophen (tried by 70%); these medications were still being used by more than one half of the patients who had tried them. Opioids produced the greatest degree of pain relief on average (mean, 6.27 ± 3.05 [SD] on a 0–10 scale, with 0 = no relief and 10 = complete relief) but were unlikely to be continued by those who tried them. Although 38% of respondents with pain had tried gabapentin, only 17% were still using it, and average pain relief was only moderate (mean, 3.32 ± 3.03 on the 0–10 relief scale). Seventy-three percent of the respondents had tried at least 1 of 7 alternative pain treatments, and the most frequently tried were massage, marijuana, and acupuncture. The most relief was provided by massage (mean, 6.05 ± 2.47] on the 0–10 relief scale) and marijuana (mean, 6.62 ± 2.54 on the 0–10 relief scale). The relief from the various treatments, including most medications, tended to last only minutes or hours; however, pain relief from alternative treatments such as massage, acupuncture, and hypnosis was reported to last for days in 25% to 33% of those who tried these treatments.
Many patients are not finding adequate pain relief from commonly prescribed medications. Alternative therapies should be considered as additional treatment options in this population.
Spinal cord injuries; Pain; Chronic; Neuropathic; Musculoskeletal; Analgesia; Gabapentin; Massage; Acupuncture; Alternative therapy
Good cancer pain control requires appropriate assessment and treatment. The purpose of this study was to examine the relationships among physician, nurse practitioner, and nurse knowledge, documentation of assessment, treatment, and pain reduction in cancer patients seen in ambulatory settings.
The study method included an assessment of pain knowledge of providers (physicians, nurse practitioners, and nurses) who worked in cancer clinics and a retrospective review of patients' records treated for cancer-related pain in their clinics. Fifty-eight providers from eight cancer clinics completed the knowledge questionnaire; 56 patient records were reviewed for assessment, treatment, and outcome data. Pain relief, the outcome, was obtained from documentation at the next clinic visit.
Of the 54 patient records that documented pain relief at the next clinic visit, 61.9% reported no relief. Chi square analysis revealed clinics with a higher level of pain knowledge documented a greater number of elements of an ideal pain assessment (p=0.03) but was unrelated to treatment and pain relief reported. Assessment and treatment were unrelated to reported pain relief at the next clinic visit.
These data suggest that providers' pain knowledge is related to pain assessment but not treatment or outcome. In addition, these data showed no relationship between assessment, treatment prescribed, and pain relief in these ambulatory settings.
Cancer pain management; Healthcare provider pain knowledge; Ambulatory settings; Cancer pain guideline
Symptomatic thoracic disc herniation is an uncommon condition and early surgical approaches were associated with significant morbidity and even mortality. We are the first to describe the technique of percutaneous thoracic nucleoplasty in three patients with severe radicular pain due to thoracic disc herniation. Two of the patients experienced more than 75% pain relief and one patient experienced more than 50% pain relief. Post-procedural pain relief was maintained up to an average of 10 months after nucleoplasty. One patient with preoperative neurological signs improved postoperatively. There were no reported complications in all three patients. In view of the reduced morbidity and shorter operating time, thoracic intervertebral disc nucleoplasty can be considered in patients with pain due to thoracic disc herniation, with no calcification of the herniated disc, and in patients who may be otherwise be unfit for conventional surgery.
Thoracic intervertebral disc herniation; Thoracic nucleoplasty; Percutaneous thoracic disc cannulation; Minimally invasive procedures
Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments.
The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.
Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.
Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.
The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared.
This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day.
Trial registration number
Dutch Trial Register NTR2551, http://www.trialregister.nl
Analgesia; Labour; Remifentanil; Patient controlled analgesia; Epidural
Morphine has been used for many years to relieve cancer pain. Oral morphine (in either immediate release or modified release form) remains the analgesic of choice for moderate or severe cancer pain. The dose of oral morphine is titrated up to achieve adequate relief from pain with minimal side effects. Antidepressant and anticonvulsant drugs, when used in addition to conventional analgesics, give excellent relief from cancer pain. Most cancer pain responds to pharmacological measures with oral morphine but some pain like neuropathic and bony pain, pain in children and elderly age group, and advanced malignancy pain are very difficult to treat. Here, we report the management of a similar patient of severe cancer pain and the difficulty that we came across during dose titration of oral morphine and adjuvant analgesic.
Adjuvant analgesic; Cancer pain; Dose titration; Oral morphine
Pain relief is a major goal for palliative care in India so much that most palliative care interventions necessarily begin first with pain relief. Physical therapists play an important role in palliative care and they are regarded as highly proficient members of a multidisciplinary healthcare team towards management of chronic pain. Pain necessarily involves three different levels of classification–based upon pain symptoms, pain mechanisms and pain syndromes. Mechanism-based treatments are most likely to succeed compared to symptomatic treatments or diagnosis-based treatments. The objective of this clinical commentary is to update the physical therapists working in palliative care, on the mechanism-based classification of pain and its interpretation, with available therapeutic evidence for providing optimal patient care using physical therapy. The paper describes the evolution of mechanism-based classification of pain, the five mechanisms (central sensitization, peripheral neuropathic, nociceptive, sympathetically maintained pain and cognitive-affective) are explained with recent evidence for physical therapy treatments for each of the mechanisms.
Mechanism-based classification; Pain rehabilitation; Pain sciences; Palliative physical therapy care
A recent article in the New Scientist argued that women were under-represented in clinical trials which, until now, had masked the finding that ibuprofen 400 mg was ineffective in women.
Meta-analysis of randomised, double-blind placebo-controlled trials of ibuprofen 400 mg in acute pain, and use of individual patient information were planned to test the hypothesis that ibuprofen is ineffective in women. For each trial the proportion of women participating, the number of patients with at least 50% pain relief and the overall event rate for ibuprofen 400 mg and placebo was calculated. For each patient percentage pain relief was calculated, and the numbers of women and men achieving at least 50% pain relief used to calculate number-needed-to-treat (NNT) for ibuprofen 400 mg compared to placebo.
Thirty-seven included trials had 3,577 patients, 67% of whom were women. The proportion with at least 50% pain relief was unaffected by how many women were included. In an analysis of 678 individual patients the proportion of women and men with at least 50% pain relief was the same, NNT 3.4 (2.6 to 4.6) and 2.5 (2.0 to 3.3) respectively.
There is no clinically meaningful difference in the efficacy of ibuprofen 400 mg between men and women experiencing moderate to severe postoperative pain and women were well represented.
Clinical trials suggest that cyclo-oxygenase-2 specific inhibitors (coxibs) are an effective treatment for acute postoperative pain. The aims of this systematic review were to examine the evidence for oral valdecoxib and injected parecoxib, and quantify efficacy and adverse effects.
Information from randomized, double-blind studies in acute postoperative pain was sought. The area under the pain relief versus time curve over four to six hours was dichotomized using validated equations to derive the proportion of patients with treatment and placebo with at least 50% pain relief over four to six hours and calculate the number-needed-to-treat (NNT). Information on duration of analgesia and adverse events was also collected.
The NNT for one patient to experience at least 50% relief over six hours following a single oral dose of valdecoxib 20 mg and 40 mg was 1.7 (1.4 to 2.0) and 1.6 (1.4 to 1.8) respectively. The NNT for one patient to have at least 50% relief over four to six hours with parecoxib 20 mg IV and 40 mg IV was 3.0 (2.3 to 4.1) and 2.3 (2.0 to 2.6) respectively. Mean time to remedication (weighted by trial size) was >24 hours with valdecoxib 40 mg, 8.7 hours with parecoxib 40 mg IV and 1.7 to 1.8 hours with placebo. There were no statistical differences between treatment and placebo for any adverse effect.
Both oral valdecoxib and injected parecoxib are effective treatments for acute postoperative pain.
Rofecoxib is a cyclo-oxygenase 2 selective inhibitor. This systematic review of rofecoxib in acute pain examined studies in adults of analgesic efficacy over six hours, the amount and quality of the evidence on extended duration of analgesia, and the quality and quantity of evidence on adverse events.
Cochrane Library (issue 4, 2001), Biological Abstracts (March 2002), MEDLINE (March 2002) and PubMed (March 2002) were searched using rofecoxib as a free text term. The area under the pain relief versus time curve was dichotomized using validated equations to derive the proportion of patients on rofecoxib 50 mg or placebo with at least 50% pain relief over six hours. This was used to calculate the number needed to treat for at least 50% pain relief over six hours for rofecoxib compared with placebo. Information on duration of analgesia and adverse events was also collected.
Five included trials investigated 1,118 patients, of whom 211 received placebo and 464 received rofecoxib 50 mg. The NNT for rofecoxib 50 mg was 2.3 (95% confidence interval 2.0 to 2.6). The weighted mean remedication time was 1.9 hours for placebo (126 patients), 7.4 hours for ibuprofen 400 mg (97 patients) and 13.6 hours for rofecoxib 50 mg (322 patients).
Rofecoxib at 2–4 times the standard daily dose for chronic pain is an effective single dose oral analgesic in acute pain. Limitations in trial reporting constrain conclusions about longer duration of analgesia and adverse event profile.
Osteoarthritis trials usually report average changes in visual analogue scale (VAS) pain, and examine the difference between treatment and placebo. We investigated whether dichotomous responder analysis provides a more informative interpretation of drug efficacy.
Merck supplied the number of patients who, by 6 weeks, had achieved pain relief compared with a baseline of 0% or more, 10% or more, 20% or more, and so on at equal intervals up to 90% or more. These different levels of pain relief were used to distinguish different definitions of responders, for example at least 50% pain relief from baseline. Numbers and percentages of patients achieving each level were identified. Information was sought from a dose–response trial over 6 weeks in osteoarthritis using placebo and using etoricoxib at 5, 10, 30 and 60 mg daily.
With placebo, the proportions of patients achieving at least 20%, 50% and 70% pain relief over baseline at 6 weeks were 30%, 11% and 2%. With 60 mg etoricoxib the equivalent percentages were 74%, 49% and 29%. The numbers needed to treat for 30 mg and 60 mg etoricoxib to produce at least 50% pain relief at 6 weeks compared with placebo were 4.2 (95% confidence interval 3.8 to 8.6) and 2.6 (2.0 to 3.9), respectively. Levels of pain relief of 50% and above discriminated best between different doses of etoricoxib.
Responder analysis seemed to be more sensitive than examination of average changes in VAS pain scores. Validation would require calculations to be performed on a set of trials using individual patient data not available in publications.