维生素C对减少急性肌肉骨骼疼痛阿片类药物用量的影响：一项双盲随机对照试验性研究。

Impact of vitamin C on the reduction of opioid consumption for acute musculoskeletal pain: A double-blind randomized control pilot study.

作者信息

Daoust Raoul, Paquet Jean, Williamson David, Huard Vérilibe, Arbour Caroline, Perry Jeffrey J, Émond Marcel, Berthelot Simon, Archambault Patrick, Rouleau Dominique, Morris Judy, Cournoyer Alexis

机构信息

Study Center in Emergency Medicine, Hôpital du Sacré-Coeur de Montréal (CIUSSS du Nord-de-l'Île de-Montréal), Montréal, Québec, Canada.

Département de Médecine Familiale et de Médecine d'Urgence, Faculté de Médecine, Université de Montréal, Montréal, Québec, Canada.

出版信息

PLoS One. 2024 Dec 31;19(12):e0316450. doi: 10.1371/journal.pone.0316450. eCollection 2024.

DOI:10.1371/journal.pone.0316450

PMID:39739762

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11687786/

Abstract

INTRODUCTION

Recent evidence has shown that vitamin C has analgesic and opioid sparing properties in immediate postoperative context. However, this has never been studied for acute musculoskeletal (MSK) emergency department (ED) injuries. The aim of this pilot study is to evaluate the feasibility of conducting a randomized placebo-controlled study to determine the opioid sparing and analgesic effect of vitamin C compared to placebo, in acute MSK injured ED patients.

METHODS

A double-blind randomized controlled trial (RCT) distributed in two arms, stratified for fractures, was performed in a tertiary care center, one group receiving 1 g of vitamin C twice a day for 14 days and another receiving placebo. Participants were ≥18 years of age, treated in ED for MSK injuries present for ≤2 weeks, and discharged with a standardized opioid prescription of 20 morphine 5 mg tablets (M5T) and, at the clinician discretion, 28 tablets of naproxen 500 mg. Participants completed a 14-day paper diary and were contacted by phone at 14 days, to document their analgesic use, vitamin C consumption, and pain intensity.

RESULTS

Overall, 137 patients were screened; 44(32%) were excluded, 38(40.9%) refused, leaving 55(59.1%) participants, with a consent rate of 9.2/month. Mean age was 53 years (SD = 16) and 55% were men. Fourteen (25%) participants were lost to follow-up and 33(83%) patients complied with treatment. For per-protocol analysis, the median (IQR) M5T consumed was 6.5 (3.3-19.5) for the vitamin C and 9.0 (1.5-16.0) for placebo group. The median (IQR) naproxen 500 mg tablets consumed was 0 (0-9.8) for the vitamin C group and 20 (0-27) for the placebo arm.

CONCLUSION

This pilot study supports the feasibility of a larger RCT on the opioid sparing and analgesic properties of vitamin C for acute MSK injured ED patients. Strategies to reduce the refusal and lost to follow-up rates are discussed.

TRIAL REGISTRATION NUMBER

NCT05555576, ClinicalTrials.Gov PRS.

摘要

引言

最近的证据表明，维生素C在术后即刻具有镇痛和节省阿片类药物的特性。然而，对于急性肌肉骨骼（MSK）急诊科（ED）损伤，尚未进行过此类研究。本初步研究的目的是评估开展一项随机安慰剂对照研究的可行性，以确定与安慰剂相比，维生素C对急性MSK损伤的ED患者的阿片类药物节省和镇痛效果。

方法

在一家三级医疗中心进行了一项双盲随机对照试验（RCT），分为两组，并按骨折情况进行分层。一组患者每天两次服用1克维生素C，持续14天，另一组服用安慰剂。参与者年龄≥18岁，因MSK损伤在ED接受治疗且病程≤2周，出院时开具标准化的阿片类药物处方，即20片5毫克吗啡片（M5T），并根据临床医生的判断，开具28片500毫克萘普生片。参与者完成一份为期14天的纸质日记，并在14天时接受电话随访，以记录他们的镇痛药物使用情况、维生素C摄入量和疼痛强度。

结果

总体而言，共筛查了137名患者；44名（32%）被排除，38名（40.9%）拒绝参与，最终有55名（59.1%）参与者，同意率为每月9.2%。平均年龄为53岁（标准差=16），男性占55%。14名（25%）参与者失访，33名（83%）患者遵守治疗方案。在符合方案分析中，维生素C组消耗的M5T中位数（IQR）为6.5（3.3 - 19.5），安慰剂组为9.0（1.5 - 16.0）。维生素C组消耗的500毫克萘普生片中位数（IQR）为0（0 - 9.8），安慰剂组为20（0 - 27）。