Total Pain Relief Research Articles

Comparison of tolerability and efficacy of a combination of paracetamol + caffeine and sumatriptan in the treatment of migraine attack: a randomized, double-blind, double-dummy, cross-over study

In this study, we compared the efficacy and tolerability of the combination of paracetamol 1,000 mg + caffeine 130 mg (PCF) with sumatriptan 50 mg (SUM) in migraine attacks. This was a multi-center randomized double-blind, double-dummy, cross-over controlled trial. The efficacy was assessed by the sum of pain intensity differences, the curve of mean pain intensity, the number of pain free at 2 h, and the total pain relief. Tolerability was assessed by recording adverse events within 4 h after drug assumption and evaluating the global judgement of patients. The comparison of these parameters did not show differences between the two drugs which resulted absolutely overlapping in pain relief and patients evaluation. In conclusion, we confirm the efficacy and safety of PCF such as SUM in the treatment of migraine attacks.

Relationship between time to onset of relief and total pain relief of breakthrough pain in patients with cancer using fentanyl pectin nasal spray.

e19544 Background: Breakthrough pain in cancer (BTPc) is typified by a rapid onset of severe pain with a limited duration. Treatment for BTPc requires rapid onset of pain relief. The main purpose of this analysis was to assess the relationship between time to onset of pain relief and overall pain relief in patients treating BTPc with fentanyl pectin nasal spray (FPNS, Lazanda, PecFent). Methods: Data were pooled from FPNS-treated episodes of 2 randomized, double-blind, crossover studies assessing efficacy of FPNS in adults who experienced BTPc despite background pain that was adequately controlled with at least 60 mg/day morphine (or equivalent). Patients initially entered a dose-titration phase to establish dose of FPNS (100 to 800 mcg) to be used during the treatment phase of each study. Pain intensity (PI) was assessed at baseline and scheduled time points on an 11-point scale (0=no pain, 10=worst possible pain). This analysis assessed the relationship of time to onset of pain relief (≥1 point reduction in PI from baseline) to total pain relief (Summed Pain Intensity Difference [SPID] at 30 and 60 min postdose [SPID30 and SPID60]) by ANOVA. Responses are also provided for the placebo-treated episodes during the placebo-controlled trial. Results: There were 831 episodes of BTPc that were treated with FPNS. Mean SPID was highest when pain relief was earliest (p<0.001). When PI difference (PID) ≥1 was attained by 5, 10, and 15 min postdose, mean (SD) SPID30 scores were 13.1 (6.7), 7.6 (4.0), and 3.5 (1.8). In the placebo-controlled trial, a similar overall response (p<0.001) was observed during the 200 placebo-treated episodes: among those attaining PID ≥1 by 5, 10, and 15 min postdose, SPID30 was 12.2 (7.0), 5.3 (3.3), and 2.5 (1.0), respectively. Similarly, significant differences were observed for SPID60 with both treatments. Conclusions: Earlier time to onset of pain intensity reduction in BTPc treatment resulted in higher SPID at 30 and 60 minutes postdose of FPNS and placebo. Results suggest that early onset of relief may be associated with a greater overall degree of relief for episodes of BTPc, which emphasizes the need for rapid-acting agents in the management of breakthrough pain.

Cancer Pain Managment with a Venom of Blue Scorpion Endemic in Cuba, Called Rhopalurus Junceus “Escozul”

During the management of cancer pain sometimes patients ask for alternative, unusual, non recognized approaches. Last year we followed a cancer patient treated with an active substance that is the venom of blue scorpions endemic to Cuba, called Rhopalurus junceus Escozul that experienced an unexpected total pain relief with a good recovery of muscle strength, vital energy and capacity to cope with daily activities such as meal, walking and interacting with relatives and caregivers. Researchers' working on the blue scorpion venom published preliminary data online referring of postulate antitumoral activity in human tumors in vivo and analgesic, anti-inflammatory and antiproliferative activities in experimental models in vitro and in vivo but unfortunately actual available clinical data are not results coming from recognized Randomized Controlled Trials supervised by appropriate IRB regulatory bodies but in a recent paper published on Toxicon in July 2011 Garcia-Gomez et al. describe the first general biochemical, molecular and functional characterization of the venom. What it is sure is this venom certainly warrant further investigation.

Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study

Background and objectives:A number of transmucosal fentanyl formulations have been developed for the management of breakthrough cancer pain (BTCP). Sublingual delivery of fentanyl, formulated as fentanyl sublingual spray, offers the potential for more rapid and greater absorption of fentanyl and associated onset of analgesic effect compared with other formulations. The objective of this study was to assess the efficacy and safety of fentanyl sublingual spray for the treatment of BTCP.Research design and methods:This was a randomized, double-blind, placebo-controlled phase III trial conducted in opioid-tolerant patients with BTCP. An open-label titration period was followed by a double-blind treatment period during which patients received fentanyl sublingual spray (100–1600 mcg) or placebo.Clinical trial registration:Trial registration: ClinicalTrials.gov identifier: NCT00538850.Main outcome measures:The primary efficacy measure was summed pain intensity difference at 30 minutes (SPID30). Secondary efficacy measures included total pain relief at 30 minutes (TOTPAR30) and patient global evaluation of study medication at 30 minutes. Efficacy measures were also assessed at various time points from 5–60 minutes postdose. Adverse events were monitored throughout the study.Results:A total of 130 patients were treated during the titration period, of whom 98 (75.4%) entered the double-blind period. Relative to placebo, fentanyl sublingual spray significantly improved mean SPID scores from 5 minutes (p = 0.0219) through 60 minutes (p < 0.0001), including the primary endpoint at 30 minutes (p < 0.0001). Fentanyl sublingual spray produced significantly greater pain relief (expressed in terms of TOTPAR) from 5 through 60 minutes (p < 0.0001), and significantly greater global evaluation of treatment effectiveness (p < 0.0001), compared with placebo. During double-blind treatment, the most frequently reported adverse events were nausea (7.1%), hyperhidrosis (5.1%), and peripheral edema (5.1%). Serious adverse events occurred in seven patients (5.4%) during titration and six (6.1%) during double-blind treatment; none were considered related to treatment.Conclusions:These findings indicate that treatment with fentanyl sublingual spray results in effective relief of BTCP, with a rapid onset of action, and is well tolerated.

Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain

Objective:Combinations of oral analgesics may offer several potential benefits compared with an individual agent. The objective of this study was to investigate the efficacy and safety of an extended-release, twice-daily fixed combination of 75 mg tramadol/650 mg paracetamol (DDS-06C) in the treatment of moderate-to-severe pain, using acute low back pain as a model.Research design and methods:In this phase III study, 277 patients with moderate-to-severe acute low back pain were randomized to 1–2 tablets of DDS-06C or placebo every 10–12 h for 2.5 days during the double-blind phase. Following the double-blind phase, patients had the option to continue for a 2.5-day open-label phase.Clinical trial registration:Clinicaltrials.gov (Identifier: NCT00643383)Main outcome measures:The primary end point was the sum of pain intensity differences (SPID) over the 50-h double-blind phase (SPID50). Secondary end points included total pain relief score over the 50-h double-blind phase (TOTPAR50), patient’s global impression of medication, and SPID over the first 4 h.Results:A statistically significant (p = 0.038) greater decrease in pain intensity was observed in the DDS-06C group (median SPID50: −6.0) versus placebo (median SPID50: −4.0). Greater pain relief was also observed in patients randomized to DDS-06C: the median TOTPAR50 was 13.0 for the DDS-06C group and 11.0 for placebo (p = 0.026). DDS-06C demonstrated statistically significant superior efficacy compared with placebo for the majority of the other secondary end points. Overall, 38% of patients treated with DDS-06C experienced at least one adverse event; the intensity was mild-to-moderate in 81% of cases. The most commonly reported adverse events (>5% of patients receiving DDS-06C) were nausea, dizziness, vomiting, and somnolence.Conclusions:Using acute low back pain, a model with a high degree of heterogeneity and intrinsic variability, DDS-06C was superior to placebo on measures of pain intensity and relief, and was well-tolerated.

Single dose oral aspirin for acute postoperative pain in adults.

This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on 'Single dose oral aspirin for acute pain'. Aspirin has been known for many years to be an effective analgesic for many different pain conditions. Although its use as an analgesic is now limited in developed countries, it is widely available, inexpensive, and remains commonly used throughout the world. To assess the analgesic efficacy and associated adverse events of single dose oral aspirin in acute postoperative pain. For the earlier review, we identified randomised trials by searching CENTRAL (The Cochrane Library) (1998, Issue 1), MEDLINE (1966 to March 1998), EMBASE (1980 to January 1998), and the Oxford Pain Relief Database (1950 to 1994). We updated searches of CENTRAL, MEDLINE, and EMBASE to January 2012. Single oral dose, randomised, double-blind, placebo-controlled trials of aspirin for relief of established moderate to severe postoperative pain in adults. We assessed studies for methodological quality and two review authors extracted the data independently. We used summed total pain relief (TOTPAR) over four to six hours to calculate the number of participants achieving at least 50% pain relief. We used these derived results to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over four to six hours. We sought numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, as additional measures of efficacy. We collected information on adverse events and withdrawals. We included 68 studies in which aspirin was used at doses from 300 mg to 1200 mg, but the vast majority of participants received either 600/650 mg (2409 participants, 64 studies) or 990/1000 mg (380 participants, eight studies). There was only one new study.Studies were overwhelmingly of adequate or good methodological quality. NNTs for at least 50% pain relief over four to six hours were 4.2 (3.9 to 4.8), 3.8 (3.0 to 5.1), and 2.7 (2.0 to 3.8) for 600/650 mg, 900/1000 mg, and 1200 mg respectively, compared with placebo. Type of pain model had no significant impact on the results. Lower doses were not significantly different from placebo. These results do not differ from those of the earlier review.Fewer participants required rescue medication with aspirin than with placebo over four to eight hours postdose, but by 12 hours there was no difference. The number of participants experiencing adverse events was not significantly different from placebo for 600/650 mg aspirin, but for 900/1000 mg the number needed to treat to harm was 7.5 (4.8 to 17). The most commonly reported events were dizziness, drowsiness, gastric irritation, nausea, and vomiting, nearly all of which were of mild to moderate severity. Aspirin is an effective analgesic for acute pain of moderate to severe intensity. High doses are more effective, but are associated with increased adverse events, including drowsiness and gastric irritation. The pain relief achieved with aspirin was very similar milligram for milligram to that seen with paracetamol. There was no change to the conclusions in this update.

Baseline and longitudinal patterns of nsaid use for symptomatic knee osteoarthritis: the OAI

Baseline and longitudinal patterns of nsaid use for symptomatic knee osteoarthritis: the OAI

Preemptive Analgesic Effect of Low Doses of Celecoxib Is Superior to Low Doses of Traditional Nonsteroidal Anti-Inflammatory Drugs

The purpose of the study was to compare the preemptive analgesic effect of celecoxib, a cyclooxygenase 2 inhibitor, with a traditional nonsteroidal anti-inflammatory drug, ibuprofen, in patients after minor oral surgery procedures. This randomized, double-blind, placebo-controlled, prospective clinical trial was conducted over an 8-month period. Participants were randomly allocated to receive a standard oral dose of 200 mg celecoxib, 400 mg ibuprofen, or a placebo containing lactose, preemptively 1 h before surgery. Using a patient diary, patients recorded pain intensity, pain relief, and global evaluations throughout the 24-hour period after dosing. The overall analgesic effect, onset of action, peak effect, and duration of effect were evaluated, with the primary end point being total pain relief over 8 hours. The safety profile was assessed on the basis of physical findings and spontaneous reports of adverse experiences. The results showed that compared with ibuprofen, celecoxib had superior analgesic effects on all measures of analgesic efficacy, including overall analgesic effect (total pain relief over 8 hours: 18.1 vs 12.2, P < 0.001), time to onset of effect (30 vs 60 minutes, P = 0.003), peak pain relief (score, 2.7 vs 2.4, P < 0.05), and duration of effect (>24 vs 7.0 hours, P < 0.001). The safety profile was similar across all treatment groups. This is the first reported study that demonstrates the superior analgesic effect of celecoxib, for the release of acute postoperative pain following surgery, when compared with the traditional nonsteroidal anti-inflammatory drug, ibuprofen. There was no safety compromise when celecoxib was used in lower doses to provide analgesia for patients who need minor surgery.

Proximal Medial Gastrocnemius Release in the Treatment of Recalcitrant Plantar Fasciitis

Isolated gastrocnemius contracture has been implicated as the cause of a number of foot and ankle conditions. Plantar fasciitis (PF) is one such condition that can be secondary to altered foot biomechanics as a result of gastrocnemius contracture. In this paper, we report our results with an isolated release of the proximal medial head of gastrocnemius for recalcitrant PF. We prospectively followed a consecutive series of 21 heels in 17 patients following a Proximal Medial Gastrocnemius Release (PMGR). PF was diagnosed clinically and confirmed radiologically in all cases. To be included, at least 1~year of conservative treatment must have been tried and an isolated gastrocnemius contracture confirmed clinically using Silfverskiold's test preoperatively. Outcome measures included a 5-point Likert scale as well as subjective and objective calf weakness assessments. Final followup was on average 24 (range, 8 to 36) months after the surgery. Seventeen of the 21 heels (81%) reported total or significant pain relief following the surgery and none reported worsening of their symptoms. The majority did not have subjective or objective evidence of calf weakness. There were no `major' complications and only one case that suffered a `minor' complication. We believe a PMGR is a simple way of treating a patient with PF who has failed to respond to conservative management. In our series, the results were favorable, the recovery fast and the morbidity low.

Assessment of the Efficacy and Safety Profiles of Aspirin and Acetaminophen With Codeine: Results From 2 Randomized, Controlled Trials in Individuals With Tension-Type Headache and Postoperative Dental Pain

BackgroundAspirin is a widely used NSAID that has been extensively studied in numerous conditions. Nonprescription analgesics, such as aspirin, are frequently used for a wide variety of common ailments, including conditions such as dental pain and tension-type headache. ObjectiveWe sought to compare the efficacy and safety profiles of aspirin, acetaminophen with codeine, and placebo in the treatment of post-operative dental pain and tension-type headache. MethodsThese were 2 randomized, double-blind, placebo-controlled, single-dose clinical trials that assigned participants (2:2:1) to receive either aspirin (1000 mg), acetaminophen (300 mg) with codeine (30 mg), or placebo. The primary efficacy end point was the sum of pain intensity differences from baseline (SPID) over 6 hours for the dental pain study and over 4 hours for the tension-type headache study. Other common analgesic measures, in addition to safety, were also evaluated. ResultsThe results of the dental pain study for aspirin and acetaminophen with codeine suggest statistically significant efficacy for all measures compared with placebo at all time points. Aspirin provided statistically significant efficacy compared with acetaminophen with codeine for SPID0–4 (P = 0.028). In the tension-type headache study, aspirin and acetaminophen with codeine provided statistically significant efficacy compared with placebo for SPID0–4 and SPID0–6 (P < 0.001) and for total pain relief (P < 0.001). There were no significant differences between aspirin and acetaminophen with codeine at any evaluation of SPID (P ≥ 0.070), complete relief (P ≥ 0.179), or time to meaningful relief (P ≥ 0.245). Regarding safety, there were no statistically significant differences between treatment groups in the incidence of adverse events in the dental pain and tension-type headache studies. ConclusionsThese 2 randomized, double-blind, placebo-controlled studies demonstrate that treatment with aspirin (1000 mg) provides statistically significant analgesic efficacy compared with placebo use and comparable efficacy with acetaminophen (300 mg) with codeine (30 mg) therapy after impacted third molar extraction and in tension- type headache.

Management of Anterior Cutaneous Nerve Entrapment Syndrome in a Cohort of 139 Patients

Anterior cutaneous nerve entrapment syndrome (ACNES) is generally neglected as a source of chronic abdominal pain. The aim of this study was to evaluate the efficacy of a diagnostic workup protocol and treatment regimen in patients with suspected ACNES. A cohort of all consecutive patients presenting with chronic abdominal pain suggestive of ACNES between 2003 and 2008 was evaluated retrospectively. Patients were offered a single diagnostic injection of 1% lidocaine into the trigger point followed by subsequent therapeutic injections including corticosteroids. If pain was refractory, an anterior neurectomy was performed. Pain scores were done using a visual analog scale for evaluation of the injection regimen and Verbal Rating Scale (1-5) for long-term efficacy. A total of 139 patients with suspected ACNES (77% women, mean age 47 ± 17 years) were evaluated. Eighty-one percent (n = 94) demonstrated a visual analog scale reduction of at least 50% after the first injection. Some 33% (n = 44) remained permanently pain-free after injection therapy only. Sixty-nine patients underwent a neurectomy, which was successful in 49 (71%). Long-term efficacy revealed in 71% (very) satisfying visual rating scale (1-2) results, whereas an additional 9% reported attenuated levels of pain (visual rating scale 3). A regimen of consecutive local trigger point injections is effective in one-thirds of patients with ACNES. Surgical neurectomy is effective in about two-thirds of the injection regimen refractory patients. Eighty percent of the entire ACNES population reports total or substantial pain relief on the long term.

Preventing Position-Related Brachial Plexus Injury with Intraoperative Somatosensory Evoked Potentials and Transcranial Electrical Motor Evoked Potentials during Anterior Cervical Spine Surgery

ABSTRACT.The use of somatosensory evoked potentials (SSEPs) to monitor upper extremity nerves during surgery is becoming more accepted as a valid and useful technique to minimize intraoperative nerve injuries. We present a case illustrating the benefit of utilizing both SSEPs and transcranial electrical motor evoked potentials (TCeMEPs) for preventing position-related injury during surgery.The patient was a 43-year-old male with a history of neck pain, along with numbness and tingling of the upper extremities. While the patient was being draped, upper extremity SSEPs diminished significantly. TCeMEP responses in the hands (abductor pollicus brevis-abductor digiti minimi; APB-ADM) vanished shortly after that, followed by the biceps and left deltoid. The surgeons were notified, and the tape on the shoulders was loosened. No improvements were noted in SSEPs nor TCeMEPs due to this intervention, so all tape was removed and the patient's arms were allowed to rest naturally upon the arm boards. Upper extremity TCeMEP responses could then be elicited and SSEPs improved shortly afterward. Surgery was completed with the arms on the arm boards. All signals remained stable for the remaining three hours of the procedure. At two months follow-up, the patient was well with total pain relief and normal upper extremity function when neurological examination was performed.This report demonstrates a case in which intraoperative neurophysiological monitoring was useful in identifying and reversing impending nerve injury during cervical spine surgery. Significant changes were seen in SSEPs as well as TCeMEPs, so we recommend that TCeMEP monitoring be considered as an adjunct to SSEPs for prevention of injury to the brachial plexus.

Dynamic impression insole in rheumatoid foot with metatarsal pain

BackgroundCustom molded insoles with metatarsal supports are used to redistribute excessive loading under the metatarsal heads in patients with metatarsalgia. However, these pressure reductions are usually insufficient for the rheumatoid foot with painful deformed metatarsal heads. We developed an effective insole made by sequential foam padding under successive walking impression. MethodsSeventeen consecutive rheumatoid arthritic outpatients with metatarsal pain participated in this repeated measures study of 7-mm flat Ethylene Vinyl Acetate, custom molded and dynamic impression insoles. Peak plantar pressure, pressure-time integral, contact area and mean force were measured by a Pedar-X mobile system. Pain levels were assessed using a Visual Analog Scale (0–10). FindingsCompared to the Ethylene Vinyl Acetate control, the metatarsal head peak pressure and pressure–time integral were significantly reduced in dynamic impression insoles by 46.3% (P<0.001) and 48.9% (P<0.001), respectively. Compared to the custom molded insole, the dynamic impression insole significantly reduced 18.3% of peak pressure (P<0.001) and 20.1% of pressure–time integral (P<0.001) by increasing 8.1% of contact area (P=0.005) at the metatarsal heads, but there were no significant differences in all variables at the heel. After using the dynamic impression insole, the mean pain score was significantly reduced from 7.6 to 1.1 (P<0.001), and six participants experienced total pain-relief in walking. InterpretationDynamic impression insoles effectively relieve metatarsal pain because of a larger weight-bearing area. Forefoot shape during walking should be taken into consideration in orthotic designs for maximum pressure reduction. Consequently, we recommend using materials with memory properties to dynamically accommodate painful metatarsal heads.

Analgesic efficacy of an ibuprofenreleasing foam dressing compared with local best practice for painful exuding wounds

To examine if wound aetiology has an effect on the pain-relieving properties of an ibuprofen-releasing foam dressing, which was previously shown to reduce pain in wounds of various aetiologies, compared with local best practice (LBP). This was a secondary analysis of data from a multicentre, randomised, parallel group trial of patients with painful exuding wounds of various aetiologies. Wound aetiology was determined at enrolment. Of 853 patients enrolled into the trial, 688 belonged to a wound aetiology subgroup that included >25 patients and were included in the analysis reported here. Patients were randomised to a dressing containing 112.5mg of ibuprofen (ibuprofen foam) or to LBP for 5 days. Patients recorded pain relief and pain intensity daily. The main endpoint was the proportion of patients who, from day 1 to day 5, reported a summed pain relief score >50% of the total maximum pain relief score (TOTPARD5>50%) and the corresponding number needed to treat (NNT) for each wound aetiology subgroup. Further analyses included the proportion of patients who, on a daily basis, reported pain relief >50% of the maximum daily pain relief, the proportion of patients who, on day 5, experienced a reduction in pain intensity of >50% of the maximum score (PIDD5>50%), and if PIDD5>50% was related to baseline pain intensity. Patients were categorised by the following five wound types: arterial, venous, and mixed arterial-venous leg ulcers, vasculitis and traumatic ulcers. The ibuprofen foam dressing was associated with significantly greater pain relief than LBP in all different wound aetiology subgroups, whether chronic or traumatic (acute). Overall, TOTPARD5>50% was 55% in the ibuprofen foam group and 24% in the LBP group (p<0.0001; NNT, 3.2). The pain intensity evaluations revealed similar results in favour of ibuprofen foam compared with LBP. No correlation was observed between PIDD5>50 and initial pain intensity. In this study, the ibuprofen foam dressing was shown to consistently relieve wound pain in exuding wounds of various aetiologies, irrespective of basal pain intensity. The data suggest that local pain relief by an ibuprofen foam dressing is possible in the most common, painful, exuding, chronic and acute/traumatic wounds and so is a safer alternative to systemic pain treatment.

Efficacy of Low-Dose Celecoxib in Patients With Acute Pain

The sore throat pain model was used to evaluate single-dose effects of celecoxib 50 and 100 mg over 6 hours in the treatment of acute pharyngeal pain. Multiple-dose effects of 50-mg bid and 100 mg followed by 50 mg over 6 to 24 hours were also evaluated. Under double-blind, randomized, placebo-controlled conditions, 269 adults with confirmed acute pharyngitis rated throat pain intensity, throat soreness, difficulty swallowing, and sore throat pain relief over 24 hours. For the primary efficacy analysis (SPID2), patients receiving celecoxib 100 mg during the first 2 hours after the first dose had significantly higher mean scores than patients in the placebo group ( P < .0003). Efficacy was also demonstrated for celecoxib 50 and 100 mg compared with placebo for all end points (including total pain relief, summed pain intensity differences, total reduction of throat soreness, and difficulty swallowing) at all time points after the first dose and after the second 50-mg dose ( P < .01). There were no differences between the dosage regimens, although a supplementary 50-mg dose of celecoxib 6 to 12 hours after the first dose appeared to provide additional efficacy over 24 hours. No serious adverse events (AEs) or discontinuations due to an AE were reported. The results of this study demonstrate that in this pain model, celecoxib is a well tolerated and efficacious analgesic in 50- and 100-mg doses. Perspective In a double-blind, randomized, placebo-controlled trial utilizing the sore throat pain model, low-dose celecoxib (50- and 100-mg doses) was well tolerated and provided effective analgesia in patients with acute pain.

Minimum efficacy criteria for comparisons between treatments using individual patient meta-analysis of acute pain trials: Examples of etoricoxib, paracetamol, ibuprofen, and ibuprofen/paracetamol combinations after third molar extraction

We defined response in acute pain trials according to percentage of maximum possible efficacy. Minimum efficacy criteria (MEC) of 0%, or at least 15%, 30%, 50%, and 70% pain relief were used to examine stability over time using total pain relief and summed pain intensity difference (SPID), sex differences, and sensitivity. We used individual patient data from placebo-controlled third molar extraction trials: 4 with single-dose oral etoricoxib 120 mg, and 2 with paracetamol, ibuprofen, and ibuprofen plus paracetamol combinations. With etoricoxib, numbers needed to treat (NNTs) were stable between response levels of at least 15% (MEC15) and 50% pain relief (MEC50), and similar for total pain relief and SPID. NNTs were higher (worse) at extremes of MEC, especially with SPID. Results for women and men were similar. NNTs of lower efficacy treatments (paracetamol 500 and 1000 mg) rose rapidly at higher MEC. NNTs of high efficacy treatments (ibuprofen plus paracetamol combinations) showed greater separation at higher MEC. The highest degree of discrimination between treatments was with MEC50 and MEC70. Etoricoxib 120 mg (NNT for ⩾50% maximum 6-hour pain relief 1.7) and ibuprofen 200/400 mg plus paracetamol 500/1000 mg (NNTs 1.5 and 1.6, respectively) produced the lowest (best) NNTs in the dental pain model. Timing of patient request for additional analgesia is an alternative analgesic efficacy outcome measure. Individual patient analyses demonstrate that the choice of minimum efficacy criteria influences numbers needed to treat and that higher minimum efficacy criteria produce greater discrimination between treatments.

Single dose oral mefenamic acid for acute postoperative pain in adults.

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID). It is most often used for treating pain of dysmenorrhoea in the short term (seven days or less), as well as mild to moderate pain including headache, dental pain, postoperative and postpartum pain. It is widely available in many countries worldwide. To assess the efficacy of single dose oral mefenamic acid in acute postoperative pain, and any associated adverse events. We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to December 2010. Single oral dose, randomised, double-blind, placebo-controlled trials of mefenamic acid for relief of established moderate to severe postoperative pain in adults. Studies were assessed for methodological quality and the data extracted by two review authors independently. Summed total pain relief (TOTPAR) or pain intensity difference (SPID) over 4 to 6 hours was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over 4 to 6 hours. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected. Four studies with 842 participants met the inclusion criteria; 126 participants were treated with mefenamic acid 500 mg, 67 with mefenamic acid 250 mg, 197 with placebo, and 452 with lignocaine, aspirin, zomepirac or nimesulide. Participants had pain following third molar extraction, episiotomy and orthopaedic surgery. The NNT for at least 50% pain relief over 6 hours with a single dose of mefenamic acid 500 mg compared to placebo was 4.0 (2.7 to 7.1), and the NNT to prevent use of rescue medication over 6 hours was 6.5 (3.6 to 29). There were insufficient data to analyse other doses or active comparators, or numbers of participants experiencing any adverse events. No serious adverse events or adverse event withdrawals were reported in these studies. Oral mefenamic acid 500 mg was effective at treating moderate to severe acute postoperative pain, based on limited data. Efficacy of other doses, and safety and tolerability could not be assessed.

Single dose oral fenoprofen for acute postoperative pain in adults.

Fenoprofen is a non-steroidal anti-inflammatory drug (NSAID), available in several different countries, but not widely used. To assess the efficacy of single dose oral fenoprofen in acute postoperative pain, and associated adverse events. We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to December 2010. Single oral dose, randomised, double-blind, placebo-controlled trials of fenoprofen for relief of established moderate to severe postoperative pain in adults. Studies were assessed for methodological quality and data extracted by two review authors independently. Summed total pain relief (TOTPAR) or pain intensity difference (SPID) over 4 to 6 hours was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over 4 to 6 hours. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected. Five studies (696 participants) met the inclusion criteria; 24 participants were treated with fenoprofen 12.5 mg, 23 with fenoprofen 25 mg, 79 with fenoprofen 50 mg, 78 with fenoprofen 100 mg, 146 with fenoprofen 200 mg, 55 with fenoprofen 300 mg, 43 with zomepirac 100 mg, 30 with morphine 8 mg, 77 with codeine 60 mg, and 141 with placebo. Participants had pain following third molar extraction, laparoscopy, minor day surgery and episiotomy. The NNT for at least 50% pain relief over 4 to 6 hours with a single dose of fenoprofen 200 mg compared to placebo was 2.3 (1.9 to 3.0). There were insufficient data to analyse other doses or active comparators, time to use of rescue medication, or numbers of participants needing rescue medication. There was no difference in numbers of participants experiencing any adverse events between fenoprofen 200 mg and placebo. No serious adverse events or adverse event withdrawals were reported in these studies. Oral fenoprofen 200 mg is effective at treating moderate to severe acute postoperative pain, based on limited data for at least 50% pain relief over 4 to 6 hours. Efficacy of other doses, other efficacy outcomes, and safety and tolerability could not be assessed.

Evaluation of the Dose Range of Etoricoxib in an Acute Pain Setting Using the Postoperative Dental Pain Model

This study was conducted to evaluate the dose range of etoricoxib in acute pain using the postoperative dental pain model further. This double-blind, randomized controlled study evaluated etoricoxib (90 and 120 mg), ibuprofen (600 mg), and acetaminophen (600 mg/codeine) (60 mg, (A/C)) in patients aged ≥ 18 years with moderate or severe pain after surgical extraction of ≥ 2 third molars (≥ 1 impacted). The patients reported pain intensity and pain relief over 24 hours. The primary efficacy endpoint was total pain relief over 6 hours (TOPAR6). Adverse events were evaluated throughout the study. There were 588 patients randomized to placebo (n=46),etoricoxib (90 mg (n=191)), etoricoxib (120 mg (n=97)), ibuprofen(2400 mg (n=192)), and A/C (n=62). The overall analgesic effect (TOPAR6) of etoricoxib (90, 120 mg) was significantly greater than that of placebo (P ≤ 0.001), and not inferior to that of ibuprofen; no discernible difference was observed between etoricoxib 90 and 120 mg. Both etoricoxib doses were superior to A/C (P ≤ 0.001). Etoricoxib (90 and 120 mg) and ibuprofen(2400 mg) were generally well tolerated and had a similar incidence of adverse events (AEs). A/C was associated with significantly more AEs that led to discontinuation (ie, nausea and vomiting). Etoricoxib (90 and 120 mg) showed similar efficacy in the postoperative dental pain model, which was noninferior to ibuprofen and superior to A/C. A higher number of tooth extractions or a higher mean impaction score may have led to a greater separation in efficacy between the 2 etoricoxib doses.

Distraction Arthroplasty of the Trapeziometacarpal Joint Without Trapeziectomy

Thumb carpometacarpal joint (CMC) arthrosis leads to pain and joint instability. Therefore, pain relief and functional restoration of the CMC joint are primary goals of surgical treatment, after failure of conservative treatment. Several options for surgical treatment were listed, ranging from simple debridement of the joint, reconstruction with tendon graft, arthroplasty, to arthrodesis. Distraction arthroplasty is a good choice for mild to moderate CMC arthrosis or instability. Ten patients with persistent basal joint pain who failed conservative treatment and having basal joint instability with significant poterolateral translation were included. They were treated by distraction arthroplasty without trapeziectomy. The functional outcome was evaluated by Patient-Rated Wrist Evaluation (PRWE) questionnaire. The Wilcoxon signed-rank test was used for analysis. The mean follow up period is 37 months (minimum 15 months). All patients achieved total or near total pain relief. Significant improvement of functional outcome was gained. The PRWE functional score showed an average improvement of 41.5 (p = 0.005). No loss of reduction or CMC joint instability was noted. Our technique (distraction arthroplasty without trapeziectomy) preserves bony and adjacent structures. It is easier and quicker than traditional arthroplasties. It serves as another effective and stable method of tendon reconstruction with a less invasive approach. A larger series is needed for further observation of validity of the procedure.