Prophylatic use of IV nalmefene to prevent epidural opioid-induced pruritus: A multicenter, randomized clinical trial.

Abstract

STUDY OBJECTIVE:

The incidence of pruritus from neuraxial opioids is about 60%. Pruritus causes discomfort and decreases the quality of recovery. This randomized double-blinded clinical trial was aimed to evaluate the prophylactic effects of a single dose IV nalmefene on the incidence and severity of epidural opioid-induced pruritus within 24 h after surgeries.

DESIGN:

A two-center, randomized, double blinded, controlled clinical trial.

SETTING:

The study was conducted from March 2022 to February 2023 at two tertiary care hospitals in China.

PATIENTS:

Patients aged between 18 and 80 years-old who underwent elective surgeries and received epidural analgesia intra- and post-operatively were screened for study enrollment. A total of 306 patients were enrolled, 302 patients underwent randomization and 296 patients were included in the final analysis.

INTERVENTIONS:

The nalmefene group was prophylactically given 0.5 μg/kg nalmefene intravenously while the control group was given the same volume of saline.

MEASUREMENTS:

The primary endpoint was the incidence of pruritus within 24 h after surgeries. The secondary endpoints included time of the first patient-reported pruritus, severity of pruritus after surgeries, severity of acute pain scores after surgeries and other anesthesia/analgesia related side effects.

MAIN RESULTS:

Pruritus occurred in 51 of the 147 (34.69%) patients in the control group and 35 of the 149 (23.49%) patients in the nalmefene group (odds ratio, 0.58; 95% CI, 0.35 to 0.96; P = 0.034) within 24 h postoperatively. Nalmefene group demonstrated delayed onset of pruritus, reduced severity of pruritus and decreased vomiting within 24 h after surgery. There were no significant differences in postoperative analgesia and the incidence of other anesthesia/analgesia associated side effects.

CONCLUSIONS:

A single dose of 0.5 μg/kg nalmefene intravenously significantly reduced the incidence and severity of epidural-opioid induced pruritus within 24 h after surgery without affecting the efficacy of epidural analgesia.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry (www.chictr.org.cn) and the registration number is ChiCTR2100050463. Registered on August 27th, 2021.

• Authors: Huan Yan, Junjun Chen, Jingwen Luo, Guiting Li, Ailun Li, Weishan Li, Ming Jiang, Juchen Li, Jiapeng Huang, Fang Fang, Jing Cang
• Journal: Journal of clinical anesthesia (J Clin Anesth) Vol. 92 Pg. 111301 (02 2024) ISSN: 1873-4529 [Electronic] United States
• PMID: 37865021 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Analgesics, Opioid
• nalmefene
• Morphine

Topics

• Humans
• Adolescent
• Young Adult
• Adult
• Middle Aged
• Aged
• Aged, 80 and over
• Analgesics, Opioid
• Morphine
• Pain, Postoperative (drug therapy, prevention & control)
• Pruritus (chemically induced, epidemiology, prevention & control)
• Analgesia, Epidural (adverse effects)
• Double-Blind Method