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25% 葡萄糖与 24% 蔗糖用于早产儿足跟采血:一项非劣效性 RCT 研究。

25% Dextrose Versus 24% Sucrose for Heel Lancing in Preterm Infants: A Noninferiority RCT.

机构信息

Departments of Neonatology.

Department of Neonatology, Government Medical College and Hospital, Sector 32, Chandigarh, India.

出版信息

Pediatrics. 2022 May 1;149(5). doi: 10.1542/peds.2021-054618.

Abstract

OBJECTIVES

To compare the efficacy of 25% dextrose with 24% sucrose for heel-lance analgesia in preterm infants admitted to the NICU.

METHODS

In this noninferiority, double-blind, randomized controlled trial, preterm infants born at 28 weeks and 0 days to 35 weeks and 6 days of gestation who were due for a scheduled heel-lance procedure were enrolled. Infants randomly assigned to the intervention arm received 0.5 mL 25% dextrose, whereas infants in the active control group received 0.5 mL 24% sucrose orally just 2 minutes before the heel-lance procedure. The primary outcome was Premature Infant Pain Profile (PIPP) score 30 seconds after the procedure. Secondary outcomes included PIPP scores at 60 and 120 seconds, PIPP-Revised scores at 30, 60, and 120 seconds, and any adverse events.

RESULTS

Sixty-four infants were enrolled (32 in each group). The mean (SD) PIPP score at 30 seconds was 6.41 (2.56) in the dextrose group and 7.03 (2.23) in the sucrose group (mean difference, -0.63 (95% confidence interval, -1.85 to 0.60; P = .31). The upper margin of the confidence interval did not cross the predefined noninferiority margin of 2. The mean PIPP scores at 60 (5.03 [2.18] vs 5.39 [1.48]) and 120 (4.75 [1.97] vs 4.94 [1.46]) seconds were also similar. The PIPP-Revised scores between the 2 groups at all time intervals were comparable. One infant in the intervention group had a transient coughing episode.

CONCLUSIONS

In preterm infants under intensive care, 25% dextrose is noninferior to 24% sucrose for heel-lance analgesia as assessed by PIPP score.

摘要

目的

比较 25%葡萄糖与 24%蔗糖用于入住新生儿重症监护病房(NICU)的早产儿足跟采血镇痛的效果。

方法

在这项非劣效性、双盲、随机对照试验中,纳入了胎龄 28 周零 0 天至 35 周加 6 天、需要进行计划性足跟采血的早产儿。将接受干预的婴儿随机分配到干预组,接受 0.5 毫升 25%葡萄糖;而主动对照组的婴儿在足跟采血前 2 分钟口服 0.5 毫升 24%蔗糖。主要结局是操作后 30 秒时早产儿疼痛状况评分(PIPP)。次要结局包括操作后 60 秒和 120 秒时的 PIPP 评分、30 秒、60 秒和 120 秒时的修订后 PIPP(PIPP-R)评分以及任何不良事件。

结果

共有 64 名婴儿入组(每组 32 名)。葡萄糖组 30 秒时的平均(SD)PIPP 评分为 6.41(2.56),蔗糖组为 7.03(2.23)(平均差,-0.63(95%置信区间,-1.85 至 0.60;P =.31)。置信区间的上限未穿过预设的非劣效性边界 2。60 秒(5.03[2.18] vs 5.39[1.48])和 120 秒(4.75[1.97] vs 4.94[1.46])时的 PIPP 评分也相似。所有时间间隔两组间的 PIPP-R 评分相似。干预组中有 1 名婴儿出现短暂咳嗽。

结论

在接受强化护理的早产儿中,与 24%蔗糖相比,25%葡萄糖用于足跟采血镇痛在 PIPP 评分方面非劣效。

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