A Randomized,Prospective Study of Efficacy and Safety of Oral Tramadol in the Management of Post‐Herpetic Neuralgia in Patients from North India

Objective: To evaluate the safety and efficacy of oral tramadol therapy (50 to 200 mg/day) in the treatment for post‐herpetic neuralgia (PHN). Methods: The study was a prospective, single‐blind, non‐responder vs. responder, randomized trial conducted in 100 outpatients of PHN after oral administration of tramadol for 4 weeks. Those patients who had achieved 50% or greater pain relief after 14 days of oral tramadol treatment were categorized as responders and those reporting < 50% pain relief were categorized as non‐responders. Rescue analgesia was provided by the topical application of a cream consisting of the combination of 3.33% doxepin and 0.05% capsaicin to the affected areas of PHN patients of both groups for at least 14 days, along with tramadol therapy. The rescue analgesia was extended to 4 weeks in patients of the non‐responder group. The primary endpoints were measured using a Numerical Rating Scale (NRS) at rest and with movement. Secondary endpoints included additional pain ratings such as global perceived effect (GPE), Neuropathic Pain Symptom Inventory scores (NPSI), daily sleep interference score (DSIS), Quality of life (QOL) as per WHO QOL‐BREF Questionnaire scores, patient and clinician ratings of global improvement. The 2 groups were compared on the basis of pain intensity scores, encompassing primary as well as secondary endpoints, and QOL after 28 days of the treatment regimen. Results: Pain intensity scores measured by NRS (at resting and with movement), NPSI, and DSIS were consistently reduced (P < 0.001) over 28 days at varying intervals in both the groups, but the magnitude of reduction was higher in responders than non‐responders. A concomitant improvement (P < 0.001) was observed in GPE on days 3, 14, and 28 as compared to the respective baseline scores in both the groups. Although the WHO QOL‐BREF scores showed significant (P < 0.001) improvement in QOL of PHN patients at days 14 and 28 in both the groups, the magnitude of improvement was higher in responders as compared to non‐responders. Significant improvement in pain intensity scores and QOL in non‐responders is mainly attributed to the use of rescue analgesia for 28 days rather than recommended tramadol therapy. Conclusions: Treatment with tramadol 50 to 200 mg per day was associated with significant pain reduction in terms of enhanced pain relief, reduced sleep interference, greater global improvement, diminished side‐effect profile, and improved QOL in PHN patients from North India. Further categorization of PHN patients may be helpful so that additional or alternative therapy may be prescribed to non‐responders.     

Antagonistic Effects of Ondansetron and Tramadol? A Randomized Placebo and Active Drug Controlled Study

Opposing effects of ondansetron and tramadol on the serotonin pathway have been suggested which possibly increase tramadol consumption and emesis when co-administered. In a randomized, double-blinded study, 179 patients received intravenous ondansetron, metoclopramide, or placebo for emesis prophylaxis. Analgesic regimen consisted of tramadol intraoperative loading and subsequent patient-controlled analgesia. Tramadol consumption and response to antiemetic treatment were compared. Additionally, plasma concentrations of ondansetron and (+)O-demethyltramadol and CYP2D6 genetic variants were analyzed as possible confounders influencing analgesic and antiemetic efficacy. Tramadol consumption did not differ between the groups. Response rate to antiemetic prophylaxis was superior in patients receiving ondansetron (85.0%) compared with placebo (66.7%, P = .046), with no difference to metoclopramide (69.5%). Less vomiting was reported in the immediate postoperative hours in the verum groups (ondansetron 5.0%, metoclopramide 5.1%) compared with placebo (18.6%; P = .01). Whereas plasma concentrations of (+)O-demethyltramadol were significantly correlated to CYP2D6 genotype, no influence was detected for ondansetron. Co-administration of ondansetron neither increased tramadol consumption nor frequency of PONV in this postoperative setting.     

曲马多自控镇痛在前列腺切除术后的应用

目的观察前列腺术后静脉和硬膜外曲马多患者自控镇痛(PCA)效果.方法90例前列腺切除患者随机分为静脉注射曲马多患者自控镇痛(PCIA)组、经硬膜外曲马多患者自控镇痛(PCEA)组和未使用术后镇痛(对照)组,每组30例.曲马多负荷量为1 mg/kg.术后定时进行镇静、镇痛评分、24 h曲马多用量、患者满意度、膀胱痉挛次数、膀胱痉挛时间、膀胱冲洗液转清时间及不良反应观察.结果PCIA和PCEA组患者术后视觉模拟评分低于对照组(P＜0.05),镇痛满意度好于对照组(P＜0.05);PCIA组24 h用药量、按键次数及VAS评分均明显低于PCEA组(P＜0.05),镇静评分、不良反应发生率与PCEA组无显著性差异.结论曲马多用于前列腺切除术后镇痛安全有效,且静脉注射镇痛效果优于硬膜外给药.     

不同剂量舒芬太尼复合曲马多用于老年髋部手术后患者静脉自控镇痛

[目的]评价不同剂量舒芬太尼复合曲马多用于老年髋部手术后静脉自控镇痛（PCIA）的效果.[方法]选择本院在连续硬膜外麻醉下择期髋部手术老年患者60例,随机分为三组.A组：舒芬太尼 50 μg ＋曲马多300 mg;B组：舒芬太尼100 μg ＋曲马多300 mg;C组：舒芬太尼150 μg ＋曲马多300 mg.三组镇痛药物均加入氟哌啶2.5 mg,用生理盐水稀释至100 mL.手术结束前连接PCA泵,镇痛模式为负荷剂量2 mL,持续剂量 1. 2 mL/h, PCA为 2 mL,锁定时间 20 min,全程观察24 h.分别于术后 2～4 h、8～10 h、12～20 h、22～24 h访视记录患者 VAS评分,镇痛药用量、PCA按压次数、Ramsay镇静评分和生命体征及不良反应.[结果]术后 24 h各时段 B、C两组 VAS评分均低于A组（P〈0.05）;与B组相比较,C组8～10 h、12～20 h VAS评分均降低（P〈0.05）;各时段 B、C两组镇痛药用量明显少于A组（P〈0.05）.在 2～4 h、8～10 h时间段 PCA有效按压次数 B、C两组明显低于 A组（P〈0.05）;三组患者各时段 Ramsay镇静评分未见明显差异.[结论]150 μg舒芬太尼复合300 mg曲马多用于老年髋部手术后患者PCIA,临床效果好,安全可靠.     

格拉斯琼预防全麻后寒战的临床观察

目的：探讨同哌替啶和曲马多比较,格拉斯琼预防全麻后寒战的临床效果。方法：120例ASAI～II级,在全麻下拟行择期手术患者,随机分为四组,每组30例：T组（曲马多1mg/kg）,G组（格拉斯琼40μg/kg）,M组（哌替啶0.4mg/kg）和P组（0.9%生理盐水）。各组药物在手术结束时通过静脉给予。记录术后寒战评分和麻醉恢复时间及镇静程度。结果：同对照组比较,格拉斯琼明显减少麻醉后寒战的发生（P〈0.01）,但同哌替啶和曲马多组比较无统计学差异（P〉0.05）。哌替啶组和曲马多组的麻醉恢复时间（20.58±3.56和16.45±4.13min）较对照组（12.61±3.31min）和格拉斯琼组（13.58±3.41min）明显延长（P〈0.05）。结论：使用40μg/kg格拉司琼同使用曲马多1mg/kg和哌替啶0.4mg/kg一样可有效地预防麻醉后寒战。     

Pharmacokinetics and postoperative analgesia of epidural tramadol: A prospective, pilot study

Background: Tramadol, a centrally acting analgesic drug, can be administered via multiple routes and is generally well tolerated.Objective: This study was designed to assess the pharmacokinetics of epidural tramadol administered preoperatively in Japanese patients undergoing upper abdominal surgery.Method: Japanese patients who were scheduled to undergo upper abdominal surgery in The Kitasato Institute Hospital, Tokyo, Japan, were included. Patients received tramadol 2 mg/kg with 5 mL of 1% mepivacaine epidurally 10 minutes before incision. The serum concentration of tramadol was determined by high-performance liquid chromatography for 21 hours after administration. Serum concentration was determined before tramadol administration and 10, 20, 30, and 60 minutes after tramadol administration, first postoperative night, and first postoperative day. Pain score and adverse events (AEs) were assessed at 1, 3, 6, 12, 18, 24, 36, and 48 hours after surgery by patient interview.Results: Eleven patients were assessed for enrollment. Seven patients (6 men, 1 woman; mean [SD] age, 61.3 [12.6] years; mean [SD] weight, 59.9 [8.9] kg) provided consent and completed the study. The mean (SD) serum C_max of tramadol was 1385.5 (390.8) ng/mL, T_max was 0.33 (0.22) hour, and terminal elimination half-life (t_1/2β) was 10.5 (2.3) hours. Four patients complained of nausea; however, only 1 patient was administered an antiemetic. No other AEs were reported.Conclusion: This pilot study found that epidural tramadol administered before incision induced a C_max within 30 minutes of administration. The drug was detected in serum at ∼21 hours after surgery.     

丙泊酚加曲马多麻醉行无痛人工流产术的观察与护理

目的　探讨两种不同静脉麻醉用药对无痛人工流产术的效果。方法　将 12 0例 4 5～ 6 0d的孕妇随机分为两组各 6 0例 ,麻醉方式 :观察组曲马多 2mg/kg静注 ,10min后静注丙泊酚 1.5mg/kg ;对照组单纯用丙泊酚 2 .5mg/kg静注 ,比较两组镇痛效果、宫颈松弛度、出血量、人流综合征发生、患者自动离院时间。结果　观察组的镇痛效果及术后自动离院时间与对照组有显著差异 (P <0 .0 1) ;但两组的宫颈松弛度、并发症和出血量无显著差异 (P >0 0 5 )。结论　丙泊酚加曲马多静脉麻醉用于无痛人流术 ,有良好的镇痛效果。     

Drugs for Treating Opioid-Induced Constipation: A Mixed Treatment Comparison Network Meta-analysis of Randomized Controlled Clinical Trials

Context

Opioid-induced constipation is a common problem associated with chronic use of opioid analgesics.

超前镇痛在小儿整形外科手术中的应用

目的:观察氟比洛芬酯与曲马多超前镇痛用于小儿整形外科术后镇痛效果及安全性。方法:小儿整形外科手术60例,随机分为三组。F组于麻醉诱导前缓慢静脉注射氟比洛芬酯1mg/kg,T组于麻醉诱导前缓慢静脉注射曲马多1.5mg/kg,C组缓慢静脉注射生理盐水2ml。观察术后0、1、4、8、12、24hVAS评分及躁动、恶心呕吐、异常出血、呼吸抑制等不良反应。结果:各时间点VAS评分:F组与T组在手术结束即时比较无明显差异,与C组比较评分较低有明显差异。其余各时间点比较F组低于T组,F组和T组低于C组,有明显差异。不良反应T组恶心呕吐高于F组与C组,有统计学意义,C组术后躁动率较F组与T组高,有统计学意义。结论:氟比洛芬酯与曲马多均能减少苏醒期躁动。氟比洛芬酯在整形外科小儿超前镇痛效果较曲马多好。