蔗糖用于接受疼痛性操作的新生儿镇痛。

Sucrose for analgesia in newborn infants undergoing painful procedures.

作者信息

Stevens B, Yamada J, Ohlsson A

出版信息

Cochrane Database Syst Rev. 2004(3):CD001069. doi: 10.1002/14651858.CD001069.pub2.

Abstract

BACKGROUND

Management of pain for neonates is less than optimal. The administration of sucrose with and without non-nutritive sucking (pacifiers) has been the most frequently studied non-pharmacological intervention for relief of procedural pain in neonates.

OBJECTIVES

To determine the efficacy, effect of dose, and safety of sucrose for relieving procedural pain as assessed by validated individual pain indicators and composite pain scores.

SEARCH STRATEGY

Standard methods as per the Neonatal Collaborative Review Group. A MEDLINE search was carried out for relevant randomized controlled trials (RCTs) published from January 1966 - March 2004, EMBASE from 1980-2004 and search of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2004). Key words and (MeSH) terms included infant/newborn, pain, analgesia and sucrose. Language restrictions were not imposed. Bibliographies, personal files, the most recent relevant neonatal and pain journals and recent major pediatric pain conference proceedings were searched manually. Unpublished studies, or studies reported only as abstracts, were not included. Additional information from published studies was obtained.

SELECTION CRITERIA

RCTs in which term and/or preterm neonates (postnatal age maximum of 28 days after reaching 40 weeks corrected gestational age) received sucrose via oral syringe, NG-tube, dropper or pacifier for procedural pain from heel lance or venepuncture. In the control group, water, pacifier or positioning/containing were used. Studies in which the painful stimulus was circumcision were excluded.

DATA COLLECTION AND ANALYSIS

Trial quality was assessed according to the methods of the Neonatal Collaborative Review Group. Quality measures included blinding of randomization, blinding of intervention, completeness of follow up and blinding of outcome measurement. Data were abstracted and independently checked for accuracy by the three investigators.

STATISTICAL ANALYSIS

The statistical package (RevMan 4.2) of the Cochrane Collaboration was used. For meta-analysis, a weighted mean difference (WMD) with 95% confidence intervals (CI) using the fixed effects model was reported for continuous outcome measures.

MAIN RESULTS

Forty-four studies were identified for possible inclusion in this review. Seven studies reported only as abstracts, and sixteen additional studies were excluded, leaving 21 studies (1,616 infants) included in this review. Sucrose in a wide variety of dosages was generally found to decrease physiologic (heart rate) and behavioural (the mean percent time crying, total cry duration, duration of first cry, and facial action) pain indicators and composite pain scores in neonates undergoing heel stick or venepuncture. When pain scores (Premature Infant Pain Profiles) were pooled across 3 studies (Gibbins 2001; Johnston 1999a; Stevens 1999), they were significantly reduced in infants who were given sucrose (dose range 0.012 g to 0.12 g) compared to the control group, [WMD -1.64 (95% CI -2.47,- 0.81); p = 0.0001] at 30 seconds and [WMD -2.05, (95% CI -3.08, -1.02); p = 0.00010] at 60 seconds after heel lance. When results for change in heart rate were pooled for two studies (Haouari 1995, Isik 2000), there were no significant differences between changes in heart rate for infants given sucrose (dose range 0.5 g to 0.6 g) compared to the control group, [WMD 0.90 (95% CI -5.81, 7.61); p = 0.8] at one minute and [WMD -6.20 (95% CI -15.27, 2.88); p = 0.18] at three minutes after heel lance.

REVIEWERS' CONCLUSIONS: Sucrose is safe and effective for reducing procedural pain from single painful events (heel lance, venepuncture). There was inconsistency in the dose of sucrose that was effective (dose range of 0.012 g to 0.12 g), and therefore an optimal dose to be used in preterm and/or term infants could not be identified. The use of repeated administrations of sucrose in neonates needs to be investigated as does the use of sucrose in combination with other behavioural (e.g., facilitated tucking, kangaroo care) and pharmacologic (e.g., morphine, fentanyl) interventions. Use of sucrose in neonates who are of very low birth weight, unstable and/or ventilated also needs to be addressed.

摘要

背景

新生儿疼痛管理尚不尽如人意。使用或不使用非营养性吸吮(安抚奶嘴)给予蔗糖,是针对缓解新生儿程序性疼痛研究最为频繁的非药物干预措施。

目的

通过经验证的个体疼痛指标和综合疼痛评分,确定蔗糖缓解程序性疼痛的疗效、剂量效应及安全性。

检索策略

采用新生儿协作审查组的标准方法。对1966年1月至2004年3月发表的相关随机对照试验(RCT)进行MEDLINE检索,检索1980年至2004年的EMBASE,并检索Cochrane对照试验中心注册库(CENTRAL,《Cochrane图书馆》,2004年第1期)。关键词和(医学主题词)术语包括婴儿/新生儿、疼痛、镇痛和蔗糖。未设语言限制。对手稿、个人文档、最新相关新生儿和疼痛期刊以及近期主要儿科疼痛会议论文集进行手工检索。未纳入未发表研究或仅以摘要形式报道的研究。获取已发表研究的其他信息。

选择标准

RCT研究中,足月儿和/或早产儿(达到40周矫正胎龄后出生年龄最大为28天)通过口服注射器、鼻胃管、滴管或安抚奶嘴接受蔗糖,以缓解足跟采血或静脉穿刺所致程序性疼痛。对照组使用水、安抚奶嘴或体位固定/包裹。排除以包皮环切术作为疼痛刺激的研究。

数据收集与分析

根据新生儿协作审查组的方法评估试验质量。质量指标包括随机分组隐匿、干预措施隐匿、随访完整性和结果测量隐匿。数据由三名研究人员提取并独立核对准确性。

统计分析

使用Cochrane协作网的统计软件包(RevMan 4.2)。对于荟萃分析,连续结果测量采用固定效应模型报告加权平均差(WMD)及95%置信区间(CI)。

主要结果

确定了44项可能纳入本综述的研究。7项研究仅以摘要形式报道,另外16项研究被排除,最终纳入本综述的有21项研究(1616例婴儿)。一般发现,各种剂量的蔗糖均可降低足跟采血或静脉穿刺新生儿的生理(心率)和行为(平均哭闹时间百分比、总哭闹时长、首次哭闹时长和面部动作)疼痛指标及综合疼痛评分。当汇总3项研究(Gibbins 2001;Johnston 1999a;Stevens 1999)的疼痛评分(早产儿疼痛量表)时,与对照组相比,给予蔗糖(剂量范围0.012 g至0.12 g)的婴儿在足跟采血后30秒时疼痛评分显著降低,[WMD -1.64(95%CI -2.47,-0.81);p = 0.0001],60秒时[WMD -2.05,(95%CI -3.08,-1.02);p = 0.00010]。当汇总两项研究(Haouari 1995,Isik 2000)的心率变化结果时,与对照组相比,给予蔗糖(剂量范围0.5 g至0.6 g)的婴儿在足跟采血后1分钟时心率变化无显著差异,[WMD 0.90(95%CI -

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