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采用冷加压试验测定志愿者吸入甲氧氟烷与静脉注射芬太尼等效镇痛剂量:一项随机、双盲、安慰剂对照交叉研究。

Determination of equi-analgesic doses of inhaled methoxyflurane versus intravenous fentanyl using the cold pressor test in volunteers: a randomised, double-blinded, placebo-controlled crossover study.

机构信息

Department of Anaesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.

Department of Anaesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.

出版信息

Br J Anaesth. 2021 May;126(5):1038-1045. doi: 10.1016/j.bja.2020.12.045. Epub 2021 Mar 4.

DOI:10.1016/j.bja.2020.12.045
PMID:33676727
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8132882/
Abstract

BACKGROUND

Inhaled methoxyflurane for acute pain relief has demonstrated an analgesic effect superior to placebo. Data comparing methoxyflurane to an opioid are needed. The aim of this study was to determine the equi-analgesic doses of inhaled methoxyflurane vs i.v. fentanyl. Both drugs have an onset within minutes and an analgesic effect of 20-30 min.

METHODS

Twelve subjects were included in a randomised, double-blinded, placebo-controlled crossover study with four treatments: placebo (NaCl 0.9%), fentanyl 25 μg i.v., fentanyl 50 μg i.v., or inhaled methoxyflurane 3 ml. The subjects reported pain intensity using the verbal numeric rating scale (VNRS) from 0 to 10 during the cold pressor test (CPT). The CPT was performed before (CPT 1), 5 min (CPT 2), and 20 min (CPT 3) after drug administration.

RESULTS

Inhaled methoxyflurane and fentanyl 25 μg reduced VNRS scores significantly compared with placebo at CPT 2 (-1.14 [estimated difference in VNRS between treatment groups with 95% confidence interval {CI}: -1.50 to -0.78]; -1.15 [95% CI: -1.51 to -0.79]; both P<0.001) and CPT 3 (-0.60 [95% CI: -0.96 to -0.24]; -0.84 [95% CI: -1.20 to -0.47]; both P<0.001). There were no significant differences between the two drugs. Methoxyflurane had significantly higher VNRS scores than fentanyl 50 μg at CPT 2 (0.90 [95% CI: 0.54-1.26]; P<0.001) and CPT 3 (0.57 [95% CI: 0.21-0.94]; P<0.001).

CONCLUSIONS

Inhaled methoxyflurane 3 ml was equi-analgesic to fentanyl 25 μg i.v. at CPT 2. Both resulted in significantly less pain than placebo. Fentanyl 50 μg i.v. demonstrated analgesia superior to methoxyflurane.

CLINICAL TRIAL REGISTRATION

NCT03894800.

摘要

背景

吸入甲氧氟烷可缓解急性疼痛,其镇痛效果优于安慰剂。需要比较甲氧氟烷和阿片类药物的效果。本研究旨在确定吸入甲氧氟烷与静脉注射芬太尼的等效镇痛剂量。这两种药物的起效时间均在数分钟内,镇痛作用持续 20-30 分钟。

方法

12 名受试者参与了一项随机、双盲、安慰剂对照交叉研究,共分为 4 种治疗组:安慰剂(0.9%生理盐水)、静脉注射芬太尼 25μg、静脉注射芬太尼 50μg、或吸入甲氧氟烷 3ml。在冷加压试验(CPT)期间,受试者使用数字评分量表(VNRS)报告疼痛强度,范围为 0 至 10。CPT 在给药前(CPT1)、5 分钟(CPT2)和 20 分钟(CPT3)后进行。

结果

与安慰剂相比,CPT2 时吸入甲氧氟烷和芬太尼 25μg 显著降低了 VNRS 评分(-1.14[治疗组间 VNRS 差值的估计值,95%置信区间(CI):-1.50 至-0.78];-1.15[95%CI:-1.51 至-0.79];均 P<0.001)和 CPT3 时(-0.60[95%CI:-0.96 至-0.24];-0.84[95%CI:-1.20 至-0.47];均 P<0.001)。两种药物之间无显著差异。CPT2 时,甲氧氟烷的 VNRS 评分显著高于芬太尼 50μg(0.90[95%CI:0.54-1.26];P<0.001),CPT3 时(0.57[95%CI:0.21-0.94];P<0.001)。

结论

CPT2 时,吸入 3ml 甲氧氟烷与静脉注射芬太尼 25μg 等效镇痛。两者均显著减轻疼痛,优于安慰剂。静脉注射芬太尼 50μg 的镇痛效果优于甲氧氟烷。

临床试验注册

NCT03894800。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/5aaec1599bc8/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/25dfccf4fe90/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/e798dfe4de25/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/b420cc7ea61c/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/9fa844e5fa26/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/5aaec1599bc8/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/25dfccf4fe90/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/e798dfe4de25/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/b420cc7ea61c/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/9fa844e5fa26/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aaa0/8132882/5aaec1599bc8/gr5.jpg

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