Department of Anesthesiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.
F1000Res. 2020 May 19;9:378. doi: 10.12688/f1000research.23455.1. eCollection 2020.
Nefopam is a non-opioid, non-steroidal, central acting drug used effectively for postoperative pain. The efficacy of nefopam for cancer pain remains unclear. We aimed to evaluate the analgesic efficacy of nefopam for cancer pain in a randomized controlled trial. : Patients with moderate to severe cancer pain (n=40) were randomly divided into two groups. The nefopam group (n=20) received three 20 mg doses of nefopam every 8 hours. The placebo group (n=20) received normal saline. Intravenous patient-controlled analgesia with morphine was given for breakthrough pain for 48 hours. The primary outcome was significant pain reduction. Secondary outcomes were morphine consumption over 48 hours and incidence of side effects. The nefopam group showed pain reduction at 12 hours (65% of patients), 24 hours (80%), 36 hours (85%), and 48 hours (65%). The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%). However, there were no statistically significant differences between the groups (p>0.05). The median dosage of morphine consumption in 48 hours was lower in the nefopam group (25.5 mg) compared with the placebo group (37 mg), but this was not statistically significant (p=0.499). There were no statistically significant differences in blood pressure and heart rate between the groups. Side effects in both groups were comparable. At dosage of 60 mg in 24 hours, nefopam did not provide significant pain reduction in moderate to severe cancer pain patients. However, there was a trend of reduced opioid consumption. Further studies with larger sample sizes, longer duration, or higher doses of nefopam are warranted. Thai Clinical Trail Registry (TCTR) ID TCTR20181016001; registered on 12 October 2018.
奈福泮是一种非阿片类、非甾体类、中枢作用药物，有效用于术后疼痛。奈福泮治疗癌痛的疗效尚不清楚。我们旨在通过一项随机对照试验评估奈福泮治疗癌痛的疗效。
：中度至重度癌痛患者（n=40）随机分为两组。奈福泮组（n=20）接受 3 次 20 mg 奈福泮，每 8 小时一次。安慰剂组（n=20）接受生理盐水。48 小时内给予静脉患者自控镇痛用吗啡治疗爆发性疼痛。主要结局是疼痛显著缓解。次要结局是 48 小时内吗啡的消耗量和不良反应的发生率。
奈福泮组在 12 小时（65%的患者）、24 小时（80%）、36 小时（85%）和 48 小时（65%）时疼痛减轻。安慰剂组在 12 小时（70%）、24 小时（75%）、36 小时（80%）和 48 小时（60%）时疼痛减轻。然而，两组之间无统计学差异（p>0.05）。48 小时内吗啡消耗的中位数剂量在奈福泮组（25.5 mg）低于安慰剂组（37 mg），但无统计学意义（p=0.499）。两组之间的血压和心率无统计学差异。两组的不良反应相当。
在 24 小时内给予 60 mg 的剂量时，奈福泮并未为中度至重度癌痛患者提供显著的疼痛缓解。然而，阿片类药物消耗有减少的趋势。需要进行更大样本量、更长时间或更高剂量的奈福泮的进一步研究。
泰国临床试验注册中心（TCTR）ID TCTR20181016001；注册于 2018 年 10 月 12 日。
