Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial
Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial
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DOI：
10.1016/s0140-6736(10)61303-7
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发表时间：
2010-10-09
期刊：
影响因子：
168.9
通讯作者：
Fitzgerald, Maria
中科院分区：
文献类型：
--
作者：
Slater, Rebeccah;Cornelissen, Laura;Fitzgerald, Maria
背景：许多入院的婴儿经历了反复的侵入性手术。口服蔗糖经常用于减轻新生儿的程序性疼痛，因为它对行为和生理疼痛评分有影响。方法在这项双盲随机对照试验中，59名英国伦敦大学学院医院的新生儿在接受临床要求的鞋跟刺激术前，被随机分配到24%蔗糖溶液0.5毫升或无菌水0.5毫升2 mm。随机化是通过计算机生成的随机化代码进行的，研究人员、临床医生、参与者和父母被掩盖了解决方案的身份。主要结果是由一个时间锁定的脚跟枪诱发的疼痛特异性脑活动，用脑电图仪记录，并通过主成分分析进行识别。次要测量是基线行为和生理测量、观察性疼痛评分(PIPP)和脊髓伤害性反射撤退活动。数据按方案进行分析。这项研究被登记，编号为ISRCTN78390996。结果29名婴儿被分配接受蔗糖治疗，30名婴儿接受消毒水治疗；分别有20名和24名婴儿被纳入主要结局指标的分析。无菌水组和蔗糖组伤害性足跟枪后脑电活动差异无统计学意义(蔗糖：平均0.10，95%CI 0.04~0.16；无菌水：平均0.08，0.04~0.12；P=0.46)。在蔗糖组和无菌水组之间，从刺激腿的股二头肌记录到的脊髓伤害性反射的幅度或潜伏期没有显著差异。服用蔗糖的婴儿的PIPP评分显著低于服用无菌水的婴儿(平均5.8分，95%CI 3.7-7.8vs8.5，7.3-9.8；p=0.02)，更多的婴儿在服用蔗糖后面部表情没有变化(7/20[35%]vs 24/24；p<0.05)。
Background Many infants admitted to hospital undergo repeated invasive procedures. Oral sucrose is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioural and physiological pain scores. We assessed whether sucrose administration reduces pain-specific brain and spinal cord activity after an acute noxious procedure in newborn infants.Methods In this double-blind, randomised controlled trial, 59 newborn infants at University College Hospital (London, UK) were randomly assigned to receive 0.5 mL 24% sucrose solution or 0.5 mL sterile water 2 mm before undergoing a clinically required heel lance. Randomisation was by a computer-generated randomisation code, and researchers, clinicians, participants, and parents were masked to the identity of the solutions. The primary outcome was pain-specific brain activity evoked by one time-locked heel lance, recorded with electroencephalography and identified by principal component analysis. Secondary measures were baseline behavioural and physiological measures, observational pain scores (PIPP), and spinal nociceptive reflex withdrawal activity. Data were analysed per protocol. This study is registered, number ISRCTN78390996.Findings 29 infants were assigned to receive sucrose and 30 to sterilised water; 20 and 24 infants, respectively, were included in the analysis of the primary outcome measure. Nociceptive brain activity after the noxious heel lance did not differ significantly between infants who received sucrose and those who received sterile water (sucrose: mean 0.10, 95% CI 0.04-0.16; sterile water: mean 0.08, 0.04-0.12; p=0.46). No significant difference was recorded between the sucrose and sterile water groups in the magnitude or latency of the spinal nociceptive reflex withdrawal recorded from the biceps femoris of the stimulated leg. The PIPP score was significantly lower in infants given sucrose than in those given sterile water (mean 5.8, 95% CI 3.7-7.8 vs 8.5, 7.3-9.8; p=0.02) and significantly more infants had no change in facial expression after sucrose administration (seven of 20 [35%] vs none of 24; p