洛芬待因缓释片对癌痛和术后痛的双盲模拟对照研究

目的 阿片类与非甾体抗炎药的复方制剂已被广泛用于缓解各类疼痛。可待因作为中枢镇痛药既可单独使用也可与其他非甾体抗炎药联合应用。观察洛芬待因(布洛芬／可待因)缓释片治疗癌痛和手术后疼痛的安全性和有效性。方法 采用双盲、双模拟、自身交叉对照法，18例癌痛患者均接受洛芬待因缓释片400/26mg、可待因片30mg、安慰剂3次服药。60例术后疼痛患者随机分为两组，分别接受洛芬待因缓释片400/26mg和可待因片30mg的治疗。结果 纳入疗效分析的合格病例共78例，洛芬待因缓释片的临床镇痛效率与可待因片相当，两药无显著性差异（P＞0．05)，但对于术后疼痛患者洛芬待因缓释片平均镇痛持续时间长于可待因，两药有显著性差异(P&;lt;0．05)。试验中未见不良反应发生。结论 洛芬待因缓释片治疗癌痛和手术后疼痛的疗效确切，不良反应少。     

高乌甲素透皮贴剂治疗中重度癌痛

目的高乌甲素具有镇痛、消炎、局麻、解热和消肿等作用,无精神依赖和积蓄作用。观察高乌甲素透皮贴剂治疗中重度癌痛的疗效。方法2003-03/2004-09在广西医科大学第一附属医院宁养院就诊的中重度癌痛患者。治疗组62例使用高乌甲素透皮贴剂2～6贴,贴于耳后无发处或胸前皮肤平坦处,72h更换1次,观察9d。对照组32例服用双氢可待因/醋氨酚复方片一两片,6h1次,24h不超过8片,观察9d。结果治疗组总有效率为83.87%52/62),对照组为78.12%(25/32),显示高乌甲素透皮(贴剂效果稍高,差异无显著性意义(P>0.05);两组对中度疼痛的止痛效果均优于重度疼痛(P<0.05)。不良反应治疗组少于对照组。结论高乌甲素透皮贴剂适用于慢性中度疼痛尤其是晚期癌痛患者。     

硫酸吗啡控释片与硫酸吗啡缓释片对重度癌痛患者镇痛效果的比较

背景吗啡是WHO倡导的治疗中重度癌症疼痛的首选药物.硫酸吗啡控释片与硫酸吗啡缓释片是口服长效吗啡.该药对解除肿瘤患者的疼痛、提高生活质量十分重要.目的观察硫酸吗啡控释片与硫酸吗啡缓释片对重度癌痛的止痛效果及对患者生活质量的影响.设计以患者为研究对象的病例分析.单位一所大学附属第一医院肿瘤科、外科、内科、中医科.对象1995-10/1998-06暨南大学附属第一医院确诊肿瘤伴重度疼痛的住院患者参加此次试验.方法182例经病理证实的中晚期重度癌痛患者,95例服用硫酸吗啡控释片,12例因药物的副作用、死亡、出院而失访,83例符合标准进入试验.87例服用硫酸吗啡缓释片,25例因药物的副作用、死亡、出院而失访,62例符合标准进入试验.初始剂量均为30 mg口服,每12 h 1次;据实际镇痛效果来调整用量,直到达到满意的镇痛效果.主要观察指标疼痛强度、疼痛缓解率及完全缓解率、缓解时间、副作用、治疗前后生活质量评分.结果硫酸吗啡控释片、硫酸吗啡缓释片的镇痛有效率分别为95%,94%.完全缓解率分别为82%,80%.镇痛有效时间分别为(9.1±4.1)h,(8.7±4.4)h.两药镇痛效果及镇痛有效时间经统计学处理差异无显著性意义(P＞0.05).治疗后分别有62例(75%),47例(76%)生活质量较前提高一个等级,治疗前后生活质量评分硫酸吗啡控释片组分别为(34.6±11.5),(52.6±13.0)分(P=0.000);硫酸吗啡缓释片组分别为(37.7±9 7),(49.8±12.9)分(P=0.000),治疗前后患者生活质量差异有显著性意义.两药对骨痛、内脏痛、软组织浸润痛效果好,对神经痛效果欠佳.结论硫酸吗啡控释片或硫酸吗啡缓释片对重度癌痛止痛效果相似,镇痛时间长,副作用小,改善了患者的生活质量.     

硫酸吗啡控释片与硫酸吗啡缓释片对重度癌痛患者镇痛效果的比较

背景：吗啡是WHO倡导的治疗中重度癌症疼痛的首选药物硫酸吗啡控释片与硫酸吗啡缓释片是口服长效吗啡该药对解除肿瘤患者的疼痛、提高生活质量十分重要。目的：观察硫酸吗啡控释片与硫酸吗啡缓释片对重度癌痛的止痛效果及对患者生活质量的影响。设计：以患者为研究对象的病例分析。单位：所大学附属第医院肿瘤科、外科、内科、中医科。对象：1995—10／1998—06暨南大学附属第一医院确诊肿瘤伴重度疼痛的住院患者参加此次试验。方法：182例经病理证实的中晚期重度癌痛患者，95例服用硫酸吗啡控释片，12例因药物的副作用、死亡、出院而失访，83例符合标准进入试验。87例服用硫酸吗啡缓释片，25例因药物的副作用、死亡、出院而失访，62例符台标准进入试验、初始剂量均为30mg口服．每12h 1次；据实际镇痛效果来凋整用量，直到达到满意的镇痛效果。主要观察指标：疼痛强度、疼痛缓解率及完全缓解率、缓解时间、副作用、治疗前后生活质量评分。结果：硫酸吗啡控释片、硫酸吗啡缓释片的镇痛有效率分别为95％、94％。完全缓解率分别为82％，80％镇痛有效时间分别为(9．1&;#177;4．1)h．(8．7&;#177;4．4)h两药镇痛效果及镇痛有效时间经统计学处理差异无显著性意义(P&;gt;0．05)。治疗后分别有62例(75％)，47例(76％)生活质量较前提高个等级，治疗前后生活质量评分硫酸吗啡控释片组分别为(34．6&;#177;11.5)，(52.6&;#177;13．0)分(P=0.000)；硫酸吗啡缓释片组分别为（37．7&;#177;9．7)，(49.8&;#177;12．9)分(P=0.000)，治疗前后患者生活质量差异有显著性意义两药对骨痛、内脏痛、软组织浸润痛效果好．对神经痛效果欠佳。结论：硫酸吗啡控释片或硫酸吗啡缓释片对重度癌痛止痛效果相似，镇痛时间长，副作用小，改善了患者的生活质量。     

丁丙诺啡含片治疗晚期癌痛初始剂量的观察

目的:临床评价初始剂量的丁丙诺啡含片对癌痛的镇痛效果及药物的不良反应。方法:各类型晚期癌症中度顽固性疼痛患者160例,随机分为两组,舌下含服丁丙诺啡含片0.2mg(实验组)80例,0.4mg(对照组)80例,连续用药1周,观察疗效及药物不良反应。结果:丁丙诺啡片用于缓解癌症中度疼痛,初始剂量0.2mg,6～8h/次,可使85%的疼痛患者得到中度以上缓解。丁丙诺啡片药物不良反应主要为头晕、恶心、呕吐等。其发生率0.4mg丁丙诺啡组略高于0.2mg丁丙诺啡组。结论:丁丙诺啡含片对晚期癌痛确有明显镇痛效果,药效维持时间长,且使用方便,不良反应轻,患者容易接受。     

吗啡缓释片治疗晚期癌痛79例观察分析

目的：观察吗啡缓释片对中、重度癌痛的镇痛效果及不良反应。方法：对79例伴有中、重度疼痛的癌症患者，给予吗啡缓释片30mg或60mg，1次／12h。观察并记录患者情况。结果：吗啡缓释片对晚期癌痛的完全缓解率达87．3％，主要不良反应为便秘、恶心、呕吐、头晕等，但症状均较轻微。结论：吗啡缓释片治疗晚期癌痛疗效确切，可有效避免成癌、呼吸抑制。     

经不同给药途径治疗癌痛的临床观察及护理干预

目的观察吗啡控缓释片与芬太尼贴剂经不同给药途径治疗中重度癌性疼痛的疗效及不良反应。方法回顾分析吗啡类控缓释片和芬太尼贴剂经不同给药途径治疗中重度疼痛327例患者的临床疗效和药物不良反应的资料。结果口服给药吗啡类控缓释片281例,经皮给药芬太尼贴剂治疗46例中,总缓解率分别是93.3%和95.6%,两者比较无统计学差异;不良反应芬太尼贴剂组略低,无统计学差异;但两种治疗对患者生存质量的提高均有显著性差异(P<0.05)。结论吗啡控缓释片及芬太尼贴剂虽然经不同给药途径,但都是临床上用以控制中重度癌痛的有效药物,能明显提高癌痛患者的生活质量。     

芬太尼贴剂治疗晚期消化道癌痛的临床观察

目的:了解芬太尼贴剂治疗晚期消化道肿瘤中、重度癌痛的镇痛效果和安全性。方法:47例晚期消化道癌痛患者,治疗前均为中、重度疼痛,均因无法口服、不能耐受口服或因肛裂、痔疮不能耐受吗啡类肛注给药者,改用芬太尼透皮贴剂,以数字评分法评定止痛疗效,研究对食欲、睡眠、情绪、一般活动、人际交往、生活乐趣的影响,并观察药物不良反应,至少观察30d。结果:全组47例患者,疼痛完全缓解9例(19.1%),明显缓解21例(44.7%),中度缓解16例(34%),总有效率为97.8%。患者生活质量明显改善,不良反应主要为便秘、恶心、呕吐、皮肤瘙痒及嗜睡等,患者可耐受。结论:芬太尼贴剂治疗中、重度消化道癌痛,镇痛效果好,不良反应发生率低,且使用方便,患者依从性强。     

盐酸羟考酮控释片治疗老年癌痛体会

目的 观察盐酸羟考酮控释片(商品名:奥施康定),治疗老年恶性肿瘤患者中、重度疼痛的临床效果及不良反应,明确该药在治疗老年癌痛中的有效性及安全性.方法 2005年3月至2009年2月中、重度疼痛老年恶性肿瘤患者(年龄≥60岁)106例,给予盐酸羟考酮控释片镇痛治疗,初始剂量10 mg/12 h,正在用吗啡类镇痛药者,按照口服吗啡1/2剂量换算,根据疼痛情况调整剂量,直至患者无痛或基本无痛,每位患者至少治疗4周以上.同时进行疼痛强度、睡眠、食欲、疲乏、精神状态、日常生活、理解配合程度评分及不良反应观察.结果 盐酸羟考酮控释片在老年癌痛患者最小有效剂量为10 mg/d,每日剂量≥200 mg的23例(21.7%),100～180 mg/d的30例(28.2%),10～90 mg/d的53例(50.0%).疼痛缓解率为97.2%,不良反应主要表现为消化道反应(便秘、恶心和呕吐),便秘较常见,需要药物干预者26例(24.53%).结论 盐酸羟考酮控释片治疗老年中、重度癌性疼痛疗效显著,耐受性良好,不良反应较少,能很好地改善老年癌症患者的生活质量.     

老年癌痛治疗中的问题及对策

近1年对480例老年癌痛患者进行了问卷调查,分析其结果可见,老年癌痛患者常接受不恰当的治疗,主要原因是对疼痛评估不充分以及药物治疗出现的副反应,影响了镇痛效果。     

Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial

BACKGROUND: In recent studies of acute pain and primary dysmenorrhea, rofecoxib, a nonsteroidal anti-inflammatory drug that selectively targets the cyclooxygenase-2 enzyme, was found to be similar in efficacy to ibuprofen and naproxen sodium. OBJECTIVE: The purpose of this study was to determine the analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with the combination of codeine 60 mg/acetaminophen 600 mg in a model of postsurgical dental pain. METHODS: In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate or severe pain after the surgical extraction of > or = 2 third molars, at least 1 of which was a mandibular impaction, were randomized to receive placebo, rofecoxib 50 mg, or codeine 60 mg/acetaminophen 600 mg. Patient evaluations of pain intensity, pain relief, and global assessments were recorded throughout the 24-hour period after dosing. The 2-stopwatch method was used to determine time to confirmed perceptible pain relief. The primary end point assessing overall analgesic effect was total pain relief over 6 hours (TOPAR6). Secondary end points were patient global assessment of response to therapy (PGART) at 6 hours, onset of analgesia, peak analgesic effect, and duration of analgesia. RESULTS: A total of 393 patients were enrolled; 182 received rofecoxib, 180 received codeine/acetaminophen, and 31 received placebo. The overall analgesic effect of rofecoxib 50 mg was greater than that of codeine 60 mg/acetaminophen 600 mg for TOPAR6 (12.4 vs 7.0; P < 0.001) and PGART at 6 hours (P < 0.001). The onset of analgesic effect was similar for rofecoxib and codeine/acetaminophen. Peak analgesic effect as measured by peak pain relief scores during the first 6 hours was significantly greater in the rofecoxib group compared with the codeine/acetaminophen group (P < 0.001), as was the duration of analgesic effect measured by the time to rescue analgesia (9.6 hours vs 2.3 hours, P < 0.001). Adverse events were reported in 33.0%, 46.1%, and 32.3% of patients treated with rofecoxib, codeine/acetaminophen, and placebo, respectively. The most common adverse events were nausea (6.0%, 25.0%, and 9.7%, respectively) and vomiting (3.8%, 18.3%, and 6.5%, respectively). Significantly more patients in the codeine/acetaminophen group than in the rofecoxib group experienced adverse events overall (P < 0.050) and nausea in particular (P < 0.001). CONCLUSION: In this study of moderate to severe postoperative dental pain, the analgesic efficacy of rofecoxib 50 mg was greater than that of codeine/acetaminophen, with a lower incidence of adverse events and nausea.     

Paracetamol with and without codeine in acute pain: a quantitative systematic review

In order to assess the analgesia obtained from single oral doses of paracetamol alone and in combination with codeine in postoperative pain, we conducted a systematic review of randomised controlled trials. We found 31 trials of paracetamol against placebo with 2515 patients, 19 trials of paracetamol plus codeine against placebo with 1204 patients and 13 trials of paracetamol plus codeine against the same dose of paracetamol with 874 patients. Pain relief information was extracted, and converted into dichotomous information (number of patients with at least 50% pain relief). Wide variations in responses to placebo (0–72%) and active drug (3–89%) were observed. In postoperative pain states paracetamol 1000 mg alone against placebo had an number-needed-to-treat (NNT) of 3.6 (3.0–4.4) and paracetamol 600/650 mg alone an NNT of 5.0 (4.1–6.9). Paracetamol 600/650 mg plus codeine 60 mg against placebo had a better NNT of 3.1 (2.6–3.8), with no overlap of 95% confidence intervals with paracetamol 600/650 mg alone. In direct comparisons of paracetamol plus codeine with paracetamol alone the additional analgesic effect of 60 mg of codeine added to paracetamol was 12 extra patients in every 100 achieving at least 50% pain relief. In indirect comparisons of each with placebo it was 14 extra patients per 100. This was an NNT for adding codeine 60 mg of 9.1 (5.8–24). The results confirm that paracetamol is an effective analgesic, and that codeine 60 mg added to paracetamol produces worthwhile additional pain relief even in single oral doses.     

Ibuprofen plus codeine, ibuprofen, and placebo in a single- and multidose cross-over comparison for coxarthrosis pain

The analgesic efficacy of 200 mg ibuprofen plus 30 mg codeine, 200 mg ibuprofen and placebo was investigated in a new analgesic evaluation model using single- and repeated-dose administration. The study was a double-blind randomized cross-over investigation in 26 coxarthrosis patients with persistent pain. After a washout period of at least 2 days with paracetamol available as rescue analgesic, each of the 3 treatments was administered in a total of 6 doses during 24 h. The hourly pain intensity was recorded on a 100-mm visual analogue scale (VAS) for 8 h after the 1st and the 6th dose. The pretreatment VAS score was 31–37 mm. After the 1st dose the 8-h mean pain intensity values were 25, 27, and 26 mm after ibuprofen plus codeine, ibuprofen, and placebo, respectively. Following another 5 doses every 4 h the corresponding values were 10, 17 and 29 mm. Repeated administration of both active drugs reduced the pain intensity significantly. The analgesic efficacy of ibuprofen plus codeine was significantly superior to that of ibuprofen which was, in turn, superior to that of placebo. In conclusion, analgesic efficacy was better differentiated after repeated-dose than after single-dose administration. The present study design was able to differentiate between 200 mg ibuprofen plus 30 mg codeine and 200 mg ibuprofen alone in a relatively small number of patients.     

A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single-center,randomized, double-blind,placebo- and active-comparator-controlled,parallel-group,single-dose study using the dental impaction pain model

BACKGROUND: Rofecoxib and celecoxib, selective cyclooxygenase-2 inhibitors, have analgesic efficacy similar to that of nonselective nonsteroidal anti-inflammatory drugs. OBJECTIVE: This study was designed to confirm earlier findings that the overall analgesic efficacy of rofecoxib 50 mg was superior to that of celecoxib 200 mg and to extend the comparison to include celecoxib 400 mg. METHODS: In this single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study, patients who experienced moderate or severe pain after surgical extraction of at least 2 third molars received a single oral dose of either rofecoxib 50 mg, celecoxib 400 mg, celecoxib 200 mg, ibuprofen 400 mg, or placebo. Patients recorded scores of pain intensity, pain relief, and global assessment at prespecified time intervals throughout the 24-hour period after dosing. The end points were total pain relief (TOPAR) score over 8 hours (TOPAR8; primary end point), TOPAR score over 12 hours (TOPAR12), sum of pain intensity difference (SPID) over 8 and 12 hours (SPID8 and SPID12), patient's global assessment of study drug at 8 hours, time to confirmed perceptible pain relief (ie, time to onset of analgesic effect), peak pain intensity difference (PID), peak pain relief, time to first dose of rescue medication (ie, duration of analgesic effect), and percentage of patients using rescue medication. RESULTS: A total of 482 patients (358 females, 124 males; mean age, 22.1 years) were enrolled. Rofecoxib 50 mg (n = 151 patients) demonstrated significantly greater overall analgesic efficacy compared with celecoxib 400 mg (n = 151), as measured by TOPAR8 (least squares mean [SE] 17.2 [0.8] vs 15.0 [0.8]; P < 0.05) and TOPAR12 (25.3 [1.2] vs 21.0 [1.2]; P < 0.05), as well as a significantly longer duration of analgesic effect (P < 0.05). Time to onset of analgesic effect and peak analgesic effect were similar for rofecoxib 50 mg and celecoxib 400 mg. Rofecoxib also showed significantly greater overall analgesic efficacy than did celecoxib 200 mg (n = 90), including greater TOPAR8 scores (17.2 [0.8] vs 11.5 [1.1]; P < 0.001), faster onset of analgesic effect (P < 0.001), greater peak analgesic effect (P < 0.001 for peak pain relief and peak PID), and longer duration of analgesic effect (P < 0.001). The overall analgesic efficacy of rofecoxib 50 mg was similar to that of ibuprofen 400 mg (n = 45), except that the duration of analgesic effect of rofecoxib 50 mg was significantly longer (P < 0.001). All active treatments produced significantly greater overall analgesic efficacy compared with that of placebo (P < 0.001 for all scores [TOPAR8, TOPAR12, SPID8, SPID12, and patient's global assessment] for all study drugs). The adverse-events (AE) profile was generally similar in all treatment groups. The 3 most common AEs were nausea, postextraction alveolitis, and vomiting. CONCLUSIONS: In this study, rofecoxib 50 mg provided generally superior overall analgesic efficacy compared with that of celecoxib 400 and 200 mg, including a significantly longer duration of analgesic effect. The overall analgesic efficacy of rofecoxib 50 mg was generally similar to that of ibuprofen 400 mg, except for a significantly longer duration of analgesic effect.     

A double-blind comparison of a new ibuprofen-codeine phosphate combination, codeine phosphate, and placebo in the relief of postepisiotomy pain

In a double-blind single-dose study, the analgesic effect of a new ibuprofen-codeine phosphate combination was compared with those of codeine phosphate alone and placebo for the relief of moderate and severe postepisiotomy pain. In the 113 patients studied, combination therapy was superior to codeine phosphate alone and to placebo, the difference between the combination and codeine phosphate alone reaching statistical significance (P less than 0.05) after two hours. The few side effects reported were not of a serious nature.     

A randomised, five-parallel-group, placebo-controlled trial comparing the efficacy and tolerability of analgesic combinations including a novel single-tablet combination of ibuprofen/paracetamol for postoperative dental pain

Combination analgesia is often recommended for the relief of severe pain. This was a double-blind, 5-arm, parallel-group, placebo-controlled, randomised, single-dose study designed to compare the efficacy and tolerability of a novel single-tablet combination of ibuprofen and paracetamol with that of an ibuprofen/codeine combination, and a paracetamol/codeine combination, using the dental impaction pain model. Subjects with at least 3 impacted third molars and experiencing moderate to severe postoperative pain were randomised to receive: 1 or 2 tablets of a single-tablet combination of ibuprofen 200 mg/paracetamol 500 mg; 2 tablets of ibuprofen 200 mg/codeine 12.8 mg; 2 tablets of paracetamol 500 mg/codeine 15 mg; or placebo. Results for the primary endpoint, the sum of the mean scores of pain relief combined with pain intensity differences over 12 hours, demonstrated that 1 and 2 tablets of the single-tablet combination of ibuprofen/paracetamol were statistically significantly more efficacious than 2 tablets of placebo (P < 0.0001) and paracetamol/codeine (P ? 0.0001); furthermore, 2 tablets offered significantly superior pain relief to ibuprofen/codeine (P = 0.0001), and 1 tablet was found noninferior to this combination. Adverse events were uncommon during this study and treatment emergent adverse events were statistically significantly less frequent in the groups taking the ibuprofen/paracetamol combination compared with codeine combinations. In conclusion, 1 or 2 tablets of a single-tablet combination of ibuprofen 200 mg/paracetamol 500 mg provided highly effective analgesia that was comparable with, or superior to, other combination analgesics currently indicated for strong pain.     

Double-blind comparison of meclofenamate sodium with codeine and placebo for the pain of episiotomy

Meclofenamate sodium, a nonsteroidal anti-inflammatory agent, was compared at two dose levels (100 mg and 200 mg) with codeine (60 mg) and placebo in a double-blind, randomized study of 218 women after normal vaginal delivery. The purpose was to determine the analgesic efficacy and safety of meclofenamate sodium for the short-term treatment of acute episiotomy pain. Meclofenamate sodium was significantly better than placebo in most measures of pain relief and reduction of pain intensity. The 100-mg dose of meclofenamate sodium was significantly better than codeine in relieving pain. Adverse experiences with the study medications were minimal (6.4%). Patients receiving codeine reported more side effects than did those receiving either dose of meclofenamate sodium. Meclofenamate sodium is a safe, effective analgesic for acute episiotomy pain.     

Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial

BACKGROUND: Opioid/acetaminophen (APAP) combination analgesics are widely prescribed for the relief of moderate pain. Tramadol is a synthetic analgesic that has been shown to be effective both alone and in combination with APAP. OBJECTIVE: The purpose of this study was to compare the efficacy and tolerability of tramadol/APAP tablets with codeine/APAP capsules. METHODS: This 4-week, randomized, double-blind, parallel-group, active-control, double-dummy, multicenter trial compared tramadol/APAP (37.5 mg/325 mg) with codeine/APAP (30 mg/300 mg) for the management of chronic nonmalignant low back pain, osteoarthritis (OA) pain, or both in adults. Pain relief (scale, 0 = none to 4 = complete) and pain intensity (scale, 0 = none to 3 = severe) were measured 30 minutes and then hourly for 6 hours after the first daily dose each week. Patients and investigators assessed the efficacy (scale, 1 = poor to 5 = excellent) of each medication, and patients recorded daily doses of study and rescue medications. RESULTS: A total of 462 patients (mean age, 57.6 years) were randomly assigned to treatment, with 112 (24%) reporting chronic low back pain, 162 (35%) reporting OA pain, and 188 (41%) reporting both low back and OA pain; 309 patients (67%) received tramadol/APAP and 153 (33%) received codeine/APAP. Pain relief and changes in pain intensity were comparable from day 1, as early as 30 minutes after the first dose, and lasted for at least 6 hours. Total pain relief scores (11.9 for tramadol/APAP; 11.4 for codeine/APAP) and sum of pain intensity differences (3.8 for tramadol/APAP; 3.3 for codeine/APAP) were also comparable throughout. Overall assessments of efficacy by patients (mean score 2.9 in each treatment group) and investigators (mean score 3.0 for tramadol/APAP, 2.9 for codeine/APAP) were similar for the 2 treatment groups. Equivalent mean doses (3.5 tablets or capsules daily) and maximum daily doses (5.5 tablets or 5.7 capsules) were used in the 2 treatment groups. The overall incidence of adverse events was comparable, with a significantly higher proportion of patients in the codeine/APAP group reporting somnolence (24% [37/153] vs 17% [54/309], P = 0.05) or constipation (21% [32/153] vs 11% [35/309], P < 0.01) and a larger proportion of patients in the tramadol/APAP group reporting headache (11% [34/309] vs 7% [11/153], P = 0.08). CONCLUSION: The results of this study suggest that tramadol/APAP tablets (37.5 mg/325 mg) are as effective as codeine/ APAP capsules (30 mg/300 mg) in the treatment of chronic nonmalignant low back pain and OA pain and are better tolerated.     

Randomized evaluation of controlled-release codeine and placebo in chronic cancer pain

Codeine is widely used in combination with acetaminophen and aspirin for the management of mild to moderate pain. However, there are few controlled clinical trials of single-entity codeine in chronic cancer pain. The purpose of this study was to evaluate the clinical efficacy and safety of controlled-release codeine given every 12 hr in patients with cancer pain. Thirty-five patients with chronic cancer pain were randomized in a double-blind crossover study to controlled-release (CR) codeine or placebo, for 7 days each. Pain intensity was assessed at 0800 hr and 2000 hr using a visual analogue scale (VAS) and a five-point categorical scale, and the use of “rescue” acetaminophen-plus-codeine (300 mg/30 mg every 4 hr as needed) was recorded. Thirty patients completed the study (17 male, 13 female; mean age, 64.4 ± 9.8 years) with a mean daily CR codeine dose of 277 ± 77 mg (range, 200–400 mg). CR codeine treatment resulted in significantly lower overall VAS pain intensity scores (22 ± 0.8 mm versus 36 ± 20 mm, P = 0.0001), categorical pain intensity scores (1.2 ± 0.8 versus 1.8 ± 0.8, P = 0.0001), and pain scores when assessed by day of treatment and by time of day. Daily “rescue” analgesic consumption was significantly lower on CR codeine, compared to placebo treatment (2.2 ± 2.3 versus 4.6 ± 2.8 tablets per day, P = 0.0001). Both patients and investigators preferred CR codeine to placebo (80% versus 3%, P = 0.0014 and 73% versus 7%, P = 0.0160, respectively). These data indicate that CR codeine, given every 12 hr results in significant reductions in pain intensity and the use of “rescue” acetaminophen-plus-codeine in patients with cancer pain. CR codeine provides the benefits of a flexible single entity codeine formulation and the convenience of 12-hr duration of action, which allows patients uninterrupted sleep and improved compliance.     

Efficacy and tolerability of diclofenac potassium sachets in acute postoperative dental pain: a placebo-controlled, randomised, comparative study vs. diclofenac potassium tablets

This double-blind, randomised, parallel-group trial compared the analgesic efficacy of single 50 mg doses of diclofenac potassium sachets and tablets with placebo in 184 patients with moderate/severe pain after third molar extraction. The primary efficacy variable was the average pain reduction from baseline during the first 2-h postdose, using a visual analogue scale (VAS). During the first 2-h postdose, sachets and tablets significantly reduced pain (p < 0.05) vs. placebo with an incremental benefit seen for sachets over tablets (p < 0.05). Onset of analgesic effect (VAS) was at 30 min for sachets and 45 min for tablets. Pain reduction vs. placebo (VAS) was maintained for 8 h for sachets and tablets (p < 0.05). VAS-findings were confirmed by pain relief and intensity verbal scale assessments. Fewer patients re-medicated vs. placebo. No safety issues were identified. This study demonstrates that both diclofenac potassium sachets and tablets offer patients suffering from acute pain conditions an effective treatment with incremental analgesic benefits seen for sachets.