蔗糖用于缓解新生儿程序性疼痛的最小有效剂量：一项随机对照试验。
The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial.
作者信息
Stevens Bonnie, Yamada Janet, Campbell-Yeo Marsha, Gibbins Sharyn, Harrison Denise, Dionne Kimberley, Taddio Anna, McNair Carol, Willan Andrew, Ballantyne Marilyn, Widger Kimberley, Sidani Souraya, Estabrooks Carole, Synnes Anne, Squires Janet, Victor Charles, Riahi Shirine
机构信息
The Hospital for Sick Children, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.
Daphne Cockwell School of Nursing, Ryerson University, 350 Victoria Street, Toronto, Ontario, M5B 2K3, Canada.
出版信息
BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x.
BACKGROUND
Orally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure.
METHODS
A total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups.
RESULTS
There was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention.
CONCLUSIONS
The minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted.
TRIAL REGISTRATION
ClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).
背景
口服蔗糖在减轻新生儿单次组织损伤性操作过程中的疼痛强度方面有效且安全，并且在新生儿疼痛指南中通常被推荐。然而，研究中所检测的蔗糖剂量存在很大差异，在新生儿护理环境中差异超过20倍。本研究的目的是确定24%蔗糖用于减轻接受单次足跟采血破皮操作的住院新生儿疼痛的最小有效剂量。
方法
来自加拿大4个三级新生儿重症监护病房（NICU）的总共245名新生儿，胎龄在24至42周之间，被前瞻性随机分为在常规足跟采血前2分钟接受三种剂量24%蔗糖中的一种，同时给予非营养性吸吮/安抚奶嘴：0.1毫升（第1组；n = 81）、0.5毫升（第2组；n = 81）或1.0毫升（第3组；n = 83）。主要结局是在足跟采血后30秒和60秒时使用修订的早产儿疼痛量表（PIPP-R）测量的疼痛强度。次要结局是不良事件的发生率。协方差分析模型，对胎龄和研究地点进行校正，以检验各干预组之间疼痛强度的组间差异。
结果
在30秒（P = 0.97）和60秒（P = 0.93）时，各治疗组之间的平均疼痛强度PIPP-R评分没有差异；然而，在足跟采血过程中疼痛并未完全消除。在245名新生儿中有5名（2.0%）报告了5起不良事件，蔗糖剂量组的事件比例没有显著差异（P = 0.62）。所有事件均在无医疗干预的情况下自行缓解。
结论
治疗新生儿单次足跟采血相关疼痛所需的24%蔗糖最小有效剂量为0.1毫升。有必要进一步评估该剂量在减轻新生儿重复疼痛操作的疼痛强度方面的持续有效性。
试验注册
ClinicalTrials.gov：NCT02134873。日期：2014年5月5日（追溯注册）。
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