Initial Visual Analog Scale Scores Research Articles

A four arm, double blind, randomized and placebo controlled study of pregabalin in the management of post-burn pruritus

Post-burn itch is a distressing symptom in burns rehabilitation and its treatment often proves frustrating for the patient and the multidisciplinary burns team. Traditionally, the mainstay of antipruritic therapy for decades has been antihistamines and massage with emollients. With a better understanding of the neurophysiology of itch emerged a new dimension in the treatment of post-burn pruritus. Gabapentin, a centrally modulating anti-epileptic agent and α2δ ligand, proved in clinical trials to be immensely better in the treatment of post-burn pruritus. Pregabalin is a newer structural analog of gabapentin. It has a much better anxiolytic effect and pharmacokinetic profile as compared to gabapentin. The current study was initiated to specifically study the role of pregabalin in relieving post-burn itch as this has never been investigated before. This double blind, randomized and placebo controlled study had four arms and was carried out on 80 adult patients (20 each). The four arms were: pregabalin, cetirizine with pheniramine maleate, combination of pregabalin, cetirizine and pheniramine maleate, and placebo (vit. B comp.). Massage with coconut oil was integral to all groups. Drug dosage was determined by initial VAS (visual analog scale) scores. All groups matched in demographic data and initial VAS scores. VAS scores were evaluated over next 28 days (days 3, 7, 14, 21 and 28). In patients with mild itch (VAS scores 2–5) or moderate itch (VAS scores 6–8) near complete remission of itch was seen in combination group and pregabalin group where the response was comparable and close to 95%. This was significantly better response than antihistaminic combination or massage alone. However, massage alone was sufficient in decreasing mean scores in mild itch, in a large percentage of patients. Amongst the patients with severe itch (VAS scores 9–10), 3/6 and 6/7 patients dropped out of trial in the antihistaminic and placebo groups, respectively. Combination therapy and pregabalin alone had exactly similar decrease in itch scores by day 28 (78.9%). This far exceeded the response in the antihistaminic and placebo groups (23.9% and 9.2% respectively). We conclude that moderate to severe pruritus (VAS 6–10) should be treated with a systemic, centrally acting agent like pregabalin or gabapentin to eliminate itch or bring it down to tolerable limits. Patients with mild itch having VAS scores between 4 and 5 may be better served with addition of pregabalin even if massage and antihistaminics can control post-burn itch to a reasonable extent because of quicker, predictable and complete response, along with anxiolysis.

Pulsed Radiofrequency of Non-neural Tissues

Pulsed radiofrequency (PRF) has been used to manage a wide spectrum of chronic pain modalities because it produces fewer histopathological changes than conventional RF and takes advantage of a significant reduction in complications or side effects [1]. Many reports have indicated that PRF improves chronic pain when applied to various neural tissues, including the dorsal root ganglion [2], cranial nerves [3], medial branches of spinal nerves [4], and other peripheral nerves [5]. Unlike neural tissues, few reports have investigated the effect of applying PRF to non-neural tissues. In the latest issue of The Korean Journal of Pain, Fukui et al. [6] reported a clinical study that compared the effects of intradiscal PRF and electrothermal therapy in 31 patients with lumbar discogenic pain. In this trial, intradiscal PRF was as effective as electrothermal therapy. At up to the 6 month follow-up, the mean numeric rating scale and Roland-Morris Disability Questionnaire score improved significantly after intradiscal PRF was applied for 15 min under conditions 5 × 50 ms/s and 60 V. Three other pilot studies, which included no control group, showed the effectiveness of intradiscal PRF for discogenic pain [7-9]. However, we are unaware of the long-term effectiveness and safety of intradiscal PRF. Further randomized controlled studies with long-term follow-up durations are crucial to verify the efficacy and safety of intradiscal PRF. The editor found a retrospective study and two case reports by PubMed search regarding the effect of intra-articular application of PRF. Karaman et al. [10] reviewed 31 patients with osteoarthritis of the knee who received intra-articular PRF retrospectively. After applying PRF at 42℃ and 2 Hz for 15 minutes, the mean initial visual analog scale scores of patients (6.1 ± 0.9) decreased to 3.9 ± 1.9 cm and 4.1 ± 1.9 cm at the 1- and 6-month follow-ups respectively. Sluijter et al. [11] reported six cases of patients with intractable arthrogenic pain who were treated with intra-articular PRF. In this case series, PRF was applied by placing an electrode into joint spaces, including the cervical facet joint, the knee joint, the sacroiliac joint, the radiocarpal joint, the shoulder joint, and the atlanto-axial joint. All participants experienced a significant reduction in pain or a pain-free state. Ozyuvaci et al. [12] reported somewhat negative results for a patient with ruptured shoulder ligaments and two patients with degeneration and osteoathrosis of the glenohumeral joint. Applying PRF to the glenohumeral joint provided some pain relief to patients at 3 weeks but not at 8 weeks. They concluded that PRF can be used as an alternative and palliative treatment with both analgesic and physiotherapeutic procedures, but that it may not be sufficient therapy for patients with chronic shoulder pain. Some case reports have described the effect of applying PRF to soft tissues, including the pain-relieving point, the trigger point, and other tissues. Lee et al. [13] reported a patient who experienced pain relief lasting more than 5 months after PRF treatment to the pain-relieving point in the posterior neck. In a case series of PRF treatment of myofascial trigger points and scar neuromas, nine patients were treated over an 18-month period [14]. Eight patients experienced 75-100% reduction in their pain following PRF treatment at 4 weeks following treatment. Six patients experienced 6 months to longer than 1 year of pain relief. Park et al. [15] observed that PRF treatment to the trapezius muscle trigger point produces long lasting myofascial pain relief. Misra et al. [16] treated chronic testicular pain with PRF stimulation of the spermatic cord in a preliminary report. Of the nine patients evaluated, four had complete pain resolution, whereas one had partial pain relief. They concluded that PRF applied to the spermatic cord appeared to be a safe, minimally invasive outpatient procedure that should be investigated further in placebo-controlled trials. Although some case reports, case series, and preliminary studies of PRF have been conducted on non-neural tissues, we do not have confirmation of the safety and the effectiveness on these tissues and do not know the exact mechanism of action. More prospective randomized controlled studies on applying PRF to non-neural tissues are mandatory to guarantee the safety and effectiveness of this therapy on such tissues. Experimental studies on histopathological and biochemical changes produced by PRF are necessary to understand the precise mode of action of PRF.

Infiltración con toxina botulínica para el control del dolor en cáncer de mama

IntroductionPain is common among patients with breast cancer, it being the leading cause of poor quality of life. Botulinum toxin (BT)may be a treatment option in these patients during breast reconstruction or in post-mastectomy pain syndrome. Very few authors have studied its effectiveness in treating pain. HypothesisInfiltration with BTin the breast muscle causes an inhibition of the muscle spasm, thus improving the pain. ObjectivesTo assess the effectiveness of BT in pain control in reconstruction with tissue expanders, breast implants and in chronic pain. Material and methodsThe study had a quasi-experimental design. The sample included 89 randomly selected patients between June 2009 and February 2011. All had breast cancer with controlled disease and painful contracture of the pectoralis major. The evaluation was performed by clinical examination and score on the visual analogue scale (VAS) before and after the infiltration. ResultsA total of 21% had undergone infiltration during reconstruction; 16% had a breast prosthesis and 63% had chronic pain. Nociceptive pain was more frequent in the expander (73.6%) and mixed chronic pain (89.2%) group. Initial VAS score was higher for the expander group that obtained greater declines after the injection. ConclusionsInfiltration of the pectoral muscle with BT type A improves pain in breast cancer subjects, both during breast reconstruction with expander and in patients with implants and in those with post-mastectomy pain syndrome.

Our percutaneous vertebroplasty applications in vertebral compression fratures

We aimed to investigate the effectiveness and complications of the percutaneous vertebroplasty (PVP) applications in vertebral compression fractures. Our study was carried out as a retrospective study in which PVP was conducted on patients with vertebral compression fractures due to benign or malignant causes between October 2006 and December 2009. The patients' pain was evaluated on a visual analog scale (VAS). In addition, the amount of cement injected, whether or not any leakage from the vertebrae corpus was seen, and any complications resulting from the application during or after the operation were recorded. The age and gender of the patients, duration of pain, number and location of fractured vertebrae, and the duration of follow-up were also collected for evaluation. A total of 15 patients were included in the assessment. Of the patients, 13 were female, and the mean age was 69.5±8.5 years. A total of 19 PVPs were applied to the 15 patients. While initial VAS scores were 7.9±1.6, at the end of an average of 10.3±3.8 (range: 4-18) months of follow-up, VAS scores had fallen to 2.6±2.7. 80% of the patients reported at least a 50% reduction in pain scores compared to initial scores, and 86.7% of them reported at least a 2-point decrease in VAS scores. In three patients, leakage of cement into the intervertebral disc occurred. PVP may be used successfully in symptomatic vertebral compression fractures not responding to medical treatment, with a low rate of complications.

Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis

Background Osteoarthritis (OA) is the most widespread chronic joint disease worldwide. Symptomatic knee OA is observed in approximately 12% of individuals more than 60 years of age. Conservative treatments models may not be effective always, and that some of them have serious adverse effects that prompted the researchers to research different treatment methods. In this study, we investigated short- and mid-term effectiveness of intra-articular pulsed radiofrequency (PRF) applied in patients with chronic knee pain due to OA. Methods This study was carried out in the pain management center of a university hospital between January 2009 and June 2009. The patient record files of 31 patients who received intra-articular PRF were retrospectively reviewed. The antero-lateral area of the knee, where the intervention would be applied, was anesthetized with 1% lidocaine. An introducer needle was placed intra-articularly. PRF was started as 42°C at 2 Hz for 15 minutes. The pain of the patients was evaluated by 10 cm Visual Analog Scale (VAS). Furthermore, the ages, the gender, the symptom duration of the patients, the side of the knee on which the intervention was applied, and the complications were collected for statistical evaluation. Results Although the mean initial VAS scores of the patients were 6.1 ± 0.9 cm, it was found, respectively, to be 3.9 ± 1.9 cm and 4.1 ± 1.9 cm at the first- and sixth-month follow-ups. In general, a decrease of 32.8% in mean in the VAS scores was achieved in the last follow-up; whereas the rate of patients reporting a minimum decrease of 2 points in the VAS scores was 64.5% and the rate of patients reporting a decrease of ≥50% in their pain was calculated as 35.5%. Conclusion PRF applied to the knee joint appears to be an effective and safe method.

A comparative analysis of cetirizine, gabapentin and their combination in the relief of post-burn pruritus

Post-burn pruritis is a very distressing symptom having a reported incidence between 80 and 100%. The mainstay of management of post-burn itch has been with antihistaminics and emollients but the treatment is ineffective in a very large percentage of patients. With the recognition of a distinct itch specific neuronal pathway, which has a complex interaction with pain pathway, a fresh approach to itch management has surfaced with the use of gabapentin. Gabapentin is an antiepileptic drug which has been successfully used to manage neuropathic pain, and is reporting to be successful in management of all forms of itch. With a paucity of randomized trials evaluating the role of gabapentin in post-burn itch management the current study was undertaken to individually evaluate gabapentin, cetirizine and their combination in relieving itch. Twenty patients were randomly recruited in each of the three groups and administered the respective drug(s) in doses determined by initial VAS (visual analog scale) scores. There was no significant difference in all the three groups with respect to mean age, sex distribution, mean percentage of TBSA burn and mean VAS score on day 0. VAS scores were evaluated over next 28 days (days 3, 7, 14, 21 and 28), and no emollients were prescribed for the study period. The initial mean VAS score reduced 95% in gabapentin group compared to 52% for the cetirizine group, which was highly significant ( p < 0.01). There was a 94% reduction in mean VAS score in the combination group which was comparable to the relief observed with gabapentin alone ( p > 0.05). Even the onset of action with gabapentin was significantly faster than the cetirizine group as evident from the mean VAS scores on day 3, which decreased 74% in gabapentin group compared to 32% in cetirizine group ( p < 0.01). Whereas all patients receiving gabapentin (either as monotherapy or in combination with cetirizine) reached an itch free status (VAS score 0–1) by day 28 only 3/20 patients reached this level with cetirizine alone. It is quite evident from this study that gabapentin is significantly better than cetirizine as monotherapy in relieving post-burn itch and it also has a faster action. The hypothetical combination of a centrally acting drug with a peripherally acting agent did not result in any better control of post-burn itch than monotherapy with gabapentin. No side effects were reported with gabapentin administration but all patients receiving cetirizine reported sedation. There is now a need to relook at the antipruritic protocols in burn management.

Bomba de infusión intratecal implantable en pacientes con dolor crónico. Evaluación de la discapacidad y la calidad de vida

Introduction Intrathecal analgesia has emerged as a therapeutic option for pain relief in patients with chronic pain in those where other forms of treatment have failed. The objective was to evaluate disability and the quality of life in patients with chronic intractable pain. Material and methods Retrospective, longitudinal and descriptive study, including 27 patients of both sexes, aged 18–85 years, in whom an intrathecal infusion pump was implanted for at least 6 months. Pain intensity was measured using the visual analogue scale (VAS), the Oswestry disability index (ODI) and quality of life prior to the Fast-Espiditest implant and at six months. Results A total of 65.38% had mixed pain, with post-laminectomy syndrome being the more frequent aetiological diagnosis (51.8%). The initial VAS score was 7.7±1 and at six-months it was 2.07±1, which was statistically significant ( P=0.00001). The initial ODI was 61.2%±10.8 (Disabled) and the final ODW was 20.2%±8.7 (minimal disability), with a statistical significance of P=0.000006. The initial Fast-Espiditest showed intense pain in 4 patients, (14%), moderate in 21 patients (77%), and mild in 2 patients (7.4%), and the final Fast-Espiditest, intense pain in 1 patient (3.7%), moderate in 4 patients (14.8%), and mild in 22 patients (81.4%). Conclusions The intrathecal infusion pump is a safe and effective device, which obtains an adequate alleviation of the pain in the patients with chronic intractable pain, improving their functionality and therefore their quality of life.

Toxina botulínica tipo A para el manejo del dolor en pacientes con síndrome de dolor miofascial crónico

Introduction Myofascial syndrome is one of the main chronic pain syndromes encountered in clinical practice and is commonly associated with trauma or repetitive microtrauma. Botulinum toxin type A (Botox ®) is an accepted therapeutic option. Objective To evaluate the use of botulinum toxin type A (Botox ®), infiltrated in trigger points, as an option in the management of pain in patients with chronic myofascial syndrome. Material and Methods Thirty men and women with myofascial pain syndrome, aged between 25 and 50 years were included. In all patients, botulinum toxin type A (Botox ®) was infiltrated in trigger points by means of electrosonomyographic equipment. A dilution of 100 Um toxin in 1 cc saline solution was used and a total of 200 to 400 Um was administered depending on the site of the pain. Analgesic quality was evaluated through a Visual Analog Scale (VAS) and the disability index was evaluated with the Oswestry questionnaire over 4 weeks. Results The mean initial VAS score was 7.23 and the mean final score was 3.13 (p < 0.01). The mean initial Oswestry index was 67.7%, decreasing to 35.5% at the end of the study (p < 0.0001). Conclusions The application of botulinum toxin type A in patients with postsurgical myofascial syndrome is effective in reducing pain intensity and in improving disability and quality of life.

Morphine analgesia in patients with acute appendicitis: a randomised double-blind clinical trial

Background:The administration of analgesics to patients with acute abdominal pain due to acute appendicitis is controversial. A study was undertaken to assess the analgesic effect of morphine in patients with...

Intradiscal Electrothermal Therapy (IDET) for Low Back Pain in Worker's Compensation Patients

This prospective study was conducted to evaluate improvements in pain and disability in a series of 53 consecutive worker's compensation patients with low back pain (LBP) after treatment with the intradiscal electrothermal therapy (IDET) procedure. All patients seen in the out-patient clinic of the Spine Institute of Louisiana for LBP of discogenic origin were screened for eligibility to receive IDET procedure. A total of 134 patients were treated using IDET for their discogenic LBP during the study period. Fifty-three patients presented to us via the worker's compensation claim program. The outcomes of these 53 patients were analyzed statistically for the current study by physical examination and self-assessment questionnaires of pain and disability at baseline and at 12-months postprocedure. Pain and disability outcomes were assessed by visual analog scale (VAS) pain score and Oswestry disability index, respectively. The mean patient age was 41.83 years (range 20 to 61 y). Whites (52.8%), African-Americans (30.2%), and Hispanics (17%) formed the majority of population. Forty-nine percent were using narcotics. The first definitive end point was considered at 12 months after the procedure. Median follow-up period was 56 months (range 29 to 72 mo). A mean reduction (P<0.001) of 62.6% in the VAS score and 69.3% in the Oswestry scores was noted after IDET. The patient's initial VAS and Oswestry scores (P<0.05) significantly affected the final outcomes. About 47.2% of the patients had some degree of economic productivity and only 7 (initial 26) consumed narcotic analgesics. IDET procedure can be a useful, safe, and cost-effective option in the management of carefully selected workers compensation claimants with chronic LBP of discogenic etiology.

Hyaluronan treatment of interstitial cystitis/painful bladder syndrome

The aim of this study is to evaluate the efficacy of intravesical hyaluronan therapy in interstitial cystitis/painful bladder syndrome (IC/PBS). One hundred twenty-six patients with IC/PBS and an average disease duration of 6.1 years were treated with weekly instillations of a 50-cm3 phosphate-buffered saline solution containing 40 mg sodium hyaluronate. To be eligible for hyaluronan treatment, a positive modified potassium test was requested as a sign of a urine-tissue barrier disorder. Data were obtained by a visual analogue scale (VAS) questionnaire rating from 0 to 10 that asked for global bladder symptoms before and after therapy. Additional questions evaluated the therapeutic impact on quality of life. A positive and durable impact of hyaluronan therapy on IC/PBS symptoms was observed--103 (85%) of the patients reported symptom improvement (> or =2 VAS units). The mean initial VAS score of 8.5 decreased to 3.5 after therapy (p < 0.0001). Out of 121 patients, 67 (55%) remained with no or minimal bladder symptoms after therapy (VAS 0-2). The majority (101, 84%) reported significant improvement of their quality of life. Intravesical therapy had to be initiated again with good success in 43 patients (34.5%) as symptoms recurred after discontinuation of treatment, while the rest stayed free of symptoms for up to 5 years. In general, hyaluronan therapy was well tolerated and, with the exception of mild irritative symptoms, no adverse reactions were reported for a total of 1,521 instillations. Timely hyaluronan instillation therapy may lead to complete symptom remission or even cure in part of the IC/PBS patients, while some responders need continuous intravesical therapy. The present results suggest that selection of patients for hyaluronan therapy by potassium testing improves the outcome of intravesical therapy with a response rate of >80%.

Fluoxetine Is Not Effective in the Treatment of Poststroke Fatigue: A Double-Blind, Placebo-Controlled Study

Background and Purpose: Although poststroke fatigue (PoSF) is common, pharmacological interventions to improve PoSF have rarely been carried out. The purpose of the present study was to evaluate the therapeutic effect of fluoxetine on PoSF. Methods: We studied 83 consecutive outpatients with PoSF at an average of 14 months after the onset of stroke. The presence of poststroke depression, poststroke emotional incontinence and poststroke anger proneness was also evaluated with the use of a standardized questionnaire. The presence of PoSF and prestroke fatigue was assessed. The visual analogue scale (VAS) and Fatigue Severity Score (FSS) were used to assess PoSF. The subjects were given either 20 mg/day of fluoxetine (n = 40) or placebo (n = 43) for 3 months. Follow-up evaluations were done 3 and 6 months after the beginning of the treatment. Results: The initial mean fatigue VAS score and the mean overall FSS score were 5.4 ± 2.0 and 4.4 ± 1.2, respectively. There were no differences in the number of patients with PoSF between the fluoxetine group and the placebo group at 3 and 6 months after the treatment. The percent changes in VAS scores and FSS at all follow-up assessments were not significantly different either. However, fluoxetine significantly improved poststroke emotional incontinence (p < 0.05) and poststroke depression (p = 0.05) in the patients with PoSF. Conclusions: Fluoxetine does not improve PoSF, although some concomitant emotional disturbances improved significantly. Our results suggest that PoSF may be associated with diverse etiologies but not closely related to serotonergic dysfunction. Further studies are required to elucidate the causative factors and to find an appropriate treatment for PoSF.

A randomized, double-blind study comparing morphine with fentanyl in prehospital analgesia

Study Objective The aim of this study was to compare, by a randomized double-blind method, morphine (M) and fentanyl (F) in a prehospital setting. Methods Consecutive patients with severe, acute pain defined as a visual analog scale score (VASS) of 60/100 or higher were included. The M group received an initial intravenous M injection of 0.1 mg/kg then of 3 mg every 5 minutes. The F group received an initial intravenous F injection of 1 μg/kg then of 30 μg every 5 minutes. The goal of analgesia was a VASS of 30/100 or lower. The end point was the VASS measured 30 minutes after initial administration (VAS [T30]). Results There were 26 patients included in the M group and 28 in the F group. Initial VASS(T0) and VASS(T30), mean (95% CI), were 83 (78-88) and 40 (28-52) in the M group and 77 (72-82) and 35 (27-43) in the F group ( P = NS). Sixty-two percent of patients in the M group described analgesia as excellent or good vs 76% of those in the F group who did ( P = NS). There were no differences in the incidence of side effects in the 2 groups. Conclusion This study demonstrates that M and F were comparable in treating severe, acute pain in a prehospital setting during the first 30 minutes in spontaneous breathing patients.

Ongoing visual analog score display improves Emergency Department pain care

The study purpose was to test two methods of pain assessment and display: ongoing (11 times over 2 h) visual analog scale (VAS) determination with data tabulation in the ED chart ( Tabulation group), and similar VAS assessments with display of the information at the head of the ED bed ( Graph group). A Control group had initial and 2-h VAS ascertainments charted (not graphed). Tertiary-care university-affiliated ED patients were randomized into the three groups and pain care outcomes assessed. Compared to Controls, those in the Graph group had the following findings ( p < 0.05): 1) treating physicians more likely aware of initial and final VAS scores, 2) earlier analgesia, 3) likelier perception (by patients and physicians) that VAS was useful and likelier patient perception that pain care was adequate. Tabulation group results were intermediate to those of Control and Graph patients. The data support further investigation of VAS display as a means of improving ED pain assessment.

Cervical radiculopathy treated with chiropractic flexion distraction manipulation: a retrospective study in a private practice setting

Background Although flexion distraction performed to the lumbar spine is commonly utilized and documented as effective, flexion distraction manipulation performed to the cervical spine has not been adequately studied. Objective To objectively quantify data from the Visual Analogue Scale (VAS) to support the clinical judgment exercised for the use of flexion distraction manipulation to treat cervical radiculopathy. Design and setting A retrospective analysis of the files of 39 patients from a private chiropractic clinic that met diagnostic criteria for inclusion. All patients were diagnosed with cervical radiculopathy and treated by a single practitioner with flexion distraction manipulation and some form of adjunctive physical medicine modality. Main outcome measures The VAS was used to objectively quantify pain. Of the 39 files reviewed, 22 contained an initial and posttreatment VAS score and were therefore utilized in this study. Results This study revealed a statistically significant reduction in pain as quantified by visual analogue scores. The mean number of treatments required was 13.2 ± 8.2, with a range of 6 to 37. Only 3 persons required more treatments than the mean plus 1 standard deviation. Conclusion The results of this study show promise for chiropractic and manual therapy techniques such as flexion distraction, as well as demonstrating that other, larger research studies must be performed for cervical radiculopathy.

A Randomized, Clinical Trial Comparing Oral Celecoxib 200 mg, Celecoxib 400 mg, and Ibuprofen 600 mg for Acute Pain

Abstract Objective: Celecoxib is a selective cyclooxygenase‐2 (COX‐2) inhibitor used to treat pain. The objective of this study was to compare the efficacies of celecoxib and ibuprofen for the treatment of acute pain. The null hypothesis was that no difference between celecoxib and ibuprofen exists. Methods: The study was a prospective, randomized, double‐blind, controlled clinical trial. After consent, patients rated their pain on a 100‐mm visual analog scale (VAS) and categorical intensity pain scale. Patients were then randomized to receive 200‐mg or 400‐mg celecoxib or 600‐mg ibuprofen (all orally). Patients were contacted 5 hours after receiving study medication when a second VAS score was recorded, along with categorical pain intensity, pain relief score, side effects, and number of rescue medications taken. The main outcome measures were change in visual analog pain and categorical pain intensity scores, and pain relief scores, at five hours. Results: One hundred ten patients were evaluated and 105 were enrolled. Thirty‐four received celecoxib 200 mg, 32 received celecoxib 400 mg, and 39 received ibuprofen 600 mg. Ninety‐one were available for the five‐hour VAS and 88 for the five‐hour categorical pain intensity and pain relief analysis: The two patients who were unable to read a VAS were excluded, and two enrolled patients withdrew prior to medication. One patient was excluded because his injury was a fracture, and therefore did not meet the inclusion criteria. There was no statistical difference among the treatment groups in age, time from injury to medication, initial VAS score, percent lost to follow‐up, or treatment with adjunctive therapy. There was no statistical difference in change of VAS among the groups at five hours: ibuprofen 600 mg (‐23.8 mm [95% CI = ‐31.56 mm to ‐16.1 mm] [n = 32]), celecoxib 200 mg (‐16.1 mm [95% CI = ‐24.3 mm to ‐7.98 mm] [n = 31]), and celecoxib 400 mg (‐12.4 mm [95% CI = ‐23.1 mm to ‐1.8 mm] [n = 30]) (p = 0.16). There was no significant difference between the groups, at five hours, in change of categorical pain intensity (p = 0.11) or pain relief scores (p = 0.059), though the pain relief scale approached significance favoring ibuprofen. Conclusions: No significant difference exists among emergency department (ED) patients treated for acute pain, at five hours, with celecoxib 200 mg, celecoxib 400 mg, or ibuprofen 600 mg, though the power of the study to detect a change was low, 36%. However, the magnitude of pain relief for celecoxib, coupled with the cost of the medication, questions its use in the immediate ED setting.

Intramuscular Droperidol versus Intramuscular Dimenhydrinate for the Treatment of Acute Peripheral Vertigo in the Emergency Department: A Randomized Clinical Trial

Objective: The emergency department (ED) treatment of acute peripheral vertigo (APV) has not been well studied. The purpose of this study was to determine the efficacy of intramuscular (IM) droperidol vs IM dimenhydrinate, in the treatment of ED patients with APV. Methods: The study was a randomized, double‐blinded clinical trial, performed at a suburban, teaching ED. A convenience sample of adult patients with symptoms and signs consistent with rigid diagnostic criteria for APV were randomized to one of two treatment groups. Patients more than 65 years of age were excluded to reduce the likelihood of diagnostic misclassification. Demographic and historical features were recorded on a standardized data form. Patients recorded their initial level (t0) of discomfort on a 10‐centimeter (cm) visual analog scale (VAS). Treatment group 1 received 2.5 mg droperidol IM, while treatment group 2 received 50 mg dimenhydrinate IM. After 30 minutes (t30), patients again recorded the severity of their symptoms on the VAS. Chi‐square, t‐tests, and Mann‐Whitney were used for statistical comparison as appropriate. All tests were two‐tailed, with alpha set at 0.05. Primary outcome parameters were the mean change in VAS score from t0 to t30, and the percentage of patients in each treatment group who felt well enough to go home after t30 without further ED intervention. Results: There were 20 patients in the droperidol group and 20 in the dimenhydrinate group. The two groups were similar with respect to mean age (40 ± 13 years droperidol vs. 42 ± 13 years dimenhydrinate; p = 0.6), female sex (60% vs. 50%; p = 0.7), and mean median duration of symptoms [3 (interquartile range 2‐12) vs 9 (interquartile range 2‐30) hours; p = 0.2]. Mean initial t0 VAS scores were 7.2 ± 2.3 and 7.8 ± 1.9 (p = 0.47). Both treatment groups had mean reductions in VAS scores at t30 of 3.3 [95% confidence interval (95% CI) = 2.3 to 4.3]. At t30, 42% of patients in the droperidol group and 45% of patients in the dimenhydrinate group felt well enough to go home without further ED intervention. Conclusions: The authors found no difference between the therapeutic efficacies of IM droperidol and dimenhydrinate for the treatment of acute peripheral vertigo.

A randomized clinical trial to assess the efficacy of intramuscular droperidol for the treatment of acute migraine headache

In a recent case series, we reported that intramuscular droperidol appeared to be an effective therapy for the treatment of acute migraine headache. The objective of the study was to further assess the efficacy of intramuscular droperidol for the treatment of acute migraine headache. The study design was a randomized, clinical trial set in a community-based ED. The population was a convenience sample of ED patients who met International Headache Society acute migraine criteria. Exclusions included pregnancy, use of narcotic or phenothiazine medications within 24 hours. For the protocol, patients were randomized to 1 of 2 treatment groups. Patients and physicians were blinded as to the treatment provided. Patients recorded their initial pain on a 100mm Visual Analog Scale (VAS) Patients were randomized to receive either 2.5 mg droperidol intramuscularly; the other group received 1.5 mg/kg meperidine intramuscularly. After 30 minutes patients recorded their pain on the VAS and recorded their preference for the medication on a Likert Scale. Physicians recorded the incidence of any side effects and the need for rescue medication. Statistical analysis consisted of categorical variables that were analyzed by chi-square, continuous interval data by t-tests and ordinal data by Mann-Whitney U test. The primary outcome parameters were mean VAS score change and the percentage of patients who wanted to go home without rescue medication. The study had an 80% power to detect a 26 mm difference in the mean change in VAS between groups. Of the 29 patients who were enrolled, 15 received droperidol. Both groups were similar with respect to age (30.7 ± 8.9 years droperdol v 32.7 ± 9.9 years meperidine; P =.59), female sex (73% v 71%; P =.91), mean headache duration (24.7 ± 28.3 v 18.3 ± 25.8 hours; P =.55). The droperidol group had a higher mean initial VAS score (88 v 76 mm; P =.03). The 2 groups were similar with regard to outcome, including: mean change in VAS score (47 v 37 mm; P =.33), average Likert score (1.1 v 1.9; P =.85), and the percentage of patients who did not want rescue medication (67% v 57%; P =.61). The incidence of sedation was 6.7 v 14.3%. Akathisia occurred in 13.3% of pts who received droperidol. We found that intramuscular droperidol was similar in efficacy to meperidine with a low incidence of side effects. (Am J Emerg Med 2002;20:39-42. Copyright © 2002 by W.B. Saunders Company)

Clinically significant changes in pain along the visual analog scale

Study Objective: We sought to test the hypothesis that the change in visual analog scale (VAS) associated with a clinically significant change in pain is related to the initial VAS score. Methods: A convenience sample of adults with isolated extremity trauma was enrolled. A VAS score was obtained on entry into the study. Descriptions of change in pain (“lot less,” “little less,” “about the same,” “little more,” or “lot more”) and VAS scores were then obtained every 30 minutes until the patient was free of pain or discharged or a total of 2 hours had passed. Patients were divided into 3 cohorts on the basis of the initial VAS score: VAS score of less than 34, VAS score of 34 to 66, and VAS score of 67 or greater. The absolute values of VAS changes associated with pain descriptions of a “little less” or “little more” (defined as clinically significant), “about the same” (defined as clinically insignificant), and “lot less” or “lot more” were calculated. Results: The change in VAS associated with clinically significant changes in pain in the cohort with VAS scores of less than 34 was 13±14 (mean±SD), which was significantly lower than that of the cohort with VAS scores of 67 or greater (28±21). There was no statistically significant difference in clinically significant changes in pain between the middle cohort and either the upper or lower cohorts (P =.07 and P =.29, respectively). There was no significant change in VAS for clinically insignificant changes in pain among the 3 cohorts (3±4, 6±6, and 8±16, respectively). Conclusion: Patients with greater pain require a greater change in VAS score to achieve clinically significant pain relief. [Bird SB, Dickson EW. Clinically significant changes in pain along the visual analog scale. Ann Emerg Med. December 2001;38:639-643.]

Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache

Study Objective: We test the hypothesis that intravenous magnesium sulfate is an effective adjunctive medication for treatment of acute migraine. Methods: In this randomized, double-blind, placebo-controlled trial, adults presenting to 2 urban emergency departments with headache meeting International Headache Society criteria for acute migraine received either 20 mg of intravenous metoclopramide plus 2 g of intravenous magnesium sulfate or 20 mg of intravenous metoclopramide plus a placebo of intravenous saline solution at 15-minute intervals for a maximum of 3 doses or until pain relief occurred. At 0, 15, 30, and 45 minutes, patients recorded pain intensity using a standard visual analog scale (VAS). The primary study end point was the between-group difference in pain improvement when initial and final VAS scores were compared. Results: Of 44 patients enrolled (21 randomized to metoclopramide plus magnesium and 23 to metoclopramide plus placebo), 42 (95%) were women. Baseline features were comparable in both groups. Each group experienced a more than 50-mm improvement in VAS score during the study. However, this improvement was smaller in the magnesium group for the primary end point (16-mm difference favoring placebo [95% confidence interval (CI) –2 to 34 mm]), as was the proportion with normal functional status at their final rating (36% absolute difference also favoring placebo [95% CI 7% to 65%]). Using a 50% reduction in pain to dichotomize VAS scores, the number needed to harm with magnesium plus metoclopramide versus metoclopramide alone is 4 patients (95% CI 2 to 36). Conclusion: Although this result was unexpected, our data suggest that the addition of magnesium to metoclopramide may attenuate the effectiveness of metoclopramide in relieving migraine. Countertherapeutic cerebral vasodilatation caused by magnesium is a plausible, although unproven, explanation for this finding. Because of the preponderance of women in our trial, these data may not be generalizable to men. [Corbo J, Esses D, Bijur PE, Iannaccone R, Gallagher EJ. Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache. Ann Emerg Med. December 2001;38:621-627.]