1 至 3 个月大需要行鼻咽抽吸术的婴儿应用口服蔗糖溶液与安慰剂对照缓解疼痛的效果：一项随机对照试验。

Effect on Pain of an Oral Sucrose Solution vs. Placebo in Children 1 to 3 Months Old Needing Nasopharyngeal Aspiration: A Randomized Controlled Trial.

机构信息

Departments of Pediatric Emergency Medicine & Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada.

Department of Pharmacy, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada.

出版信息

J Emerg Med. 2021 Aug;61(2):151-156. doi: 10.1016/j.jemermed.2021.02.021. Epub 2021 Mar 29.

DOI:10.1016/j.jemermed.2021.02.021

PMID:33795167

Abstract

BACKGROUND

Oral sweet solutions have been proposed as effective pain-reducing agents for procedures.

OBJECTIVES

To compare the efficacy of an oral sucrose solution vs. placebo in alleviating pain in children (1-3 months) during nasopharyngeal aspiration (NPA).

METHODS

A randomized, double-blind, controlled clinical trial was conducted in a pediatric hospital emergency department. Participants (aged 1-3 months) requiring NPA were randomly allocated to receive 2 mL of 88% sucrose (SUC) or 2 mL of a placebo (PLA) 2 min prior to the procedure. The primary outcome was the mean difference in pain scores at 1 min post NPA as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale.

RESULTS

Seventy-two participants completed the study, 37 receiving SUC and 35 PLA. The mean difference in FLACC scores compared with baseline was 3.3 (2.5-4.1) for SUC vs. 3.2 (2.3-4.1) for PLA (p = .094) at 1 min and -1.2 (-1.7-0.7) for SUC vs. -0.8 (-1.5 to -0.1) for PLA (p = 0.66) at 3 min after NPA. For the Neonatal Infant Pain Scale scores, it was 2.3 (1.6-3.0) (SUC) vs. 2.5 (1.8-3.2) (PLA) (p = .086) at 1 min and -1.2 (-1.6 to -0.8) (SUC) vs. -0.8 (-1.3 to 0.2) (PLA) (p = 0.59) 3 min after NPA. There was no difference in the mean crying time, 114 (98-130) s, SUC vs. 109 (92-126) s, PLA (p = 0.81). No significant difference was found in participants' heart rate at 1 min 174 (154-194) beats/min in SUC vs. 179 (160-198) beats/min in PLA (p = 0.32).

CONCLUSIONS

In infants (1-3 months) undergoing NPA, administration of an oral sweet solution did not statistically decrease pain scores.

摘要

背景

口服甜味溶液已被提议作为减轻疼痛的有效手段，用于各种操作。

目的

比较口服蔗糖溶液与安慰剂在减轻鼻咽抽吸（NPA）过程中 1-3 个月婴儿疼痛的效果。

方法

在一家儿科医院急诊室进行了一项随机、双盲、对照临床试验。需要进行 NPA 的参与者（1-3 个月大）在操作前 2 分钟随机分配接受 2 毫升 88%蔗糖（SUC）或 2 毫升安慰剂（PLA）。主要结局是通过面部、腿部、活动、哭泣和安抚（FLACC）疼痛量表评估的 NPA 后 1 分钟时疼痛评分的平均差异。

结果

72 名参与者完成了研究，37 名接受 SUC，35 名接受 PLA。与基线相比，SUC 的 FLACC 评分平均差异为 3.3（2.5-4.1），而 PLA 为 3.2（2.3-4.1）（p=0.094），在 NPA 后 1 分钟时，SUC 的评分差异为-1.2（-1.7-0.7），而 PLA 的评分差异为-0.8（-1.5 至-0.1）（p=0.66）。对于新生儿疼痛量表评分，SUC 为 2.3（1.6-3.0），PLA 为 2.5（1.8-3.2）（p=0.086），在 NPA 后 1 分钟时，SUC 的评分差异为-1.2（-1.6 至-0.8），而 PLA 的评分差异为-0.8（-1.3 至 0.2）（p=0.59）。在 NPA 后 3 分钟时，SUC 的平均哭泣时间为 114（98-130）秒，与 PLA 的 109（92-126）秒相比，无显著差异（p=0.81）。SUC 的参与者心率在 1 分钟时为 174（154-194）次/分，与 PLA 的 179（160-198）次/分相比，无显著差异（p=0.32）。