Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit

Ng E, Taddio A, Ohlsson A

Published Online:

January 20, 2010

There is no evidence to show the benefit of midazolam as a sedative for newborn babies in neonatal intensive care. Newborn babies undergoing uncomfortable procedures in intensive care units may need sedation to reduce stress and avoid complications. It is difficult to measure their pain so sedatives or pain killers are sometimes overlooked for newborn babies. Midazolam is a short acting sedative increasingly used in neonatal intensive care. The review of trials found no evidence to support the use of midazolam as a sedative for neonates undergoing intensive care. Babies receiving midazolam stayed in hospital longer and had more adverse effects. More research is needed to address the safety and effect of midazolam.

Abstract (click to read)

Background:

Proper sedation for neonates undergoing uncomfortable procedures may reduce stress and avoid complications. Midazolam is a short acting benzodiazepine that is increasingly used in neonatal intensive care units (NICU). However, its effectiveness as a sedative in neonates has not been systematically evaluated.

Objectives:

To determine whether intravenous midazolam infusion is an effective sedative, as evaluated by behavioural and/or physiologic measurements, for critically ill neonates undergoing intensive care and to assess clinically significant short and long-term adverse effects associated with its use.

Search strategy:

We performed the literature search according to the Cochrane Neonatal Review Group search strategy. Randomized and quasi-randomized controlled trials of intravenous midazolam use in neonates were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2009), MEDLINE (1985 to 2009), EMBASE (1980 to 2009), CINAHL (1981 to 2009), reference lists of published studies, personal files, and abstracts published in Pediatric Research from 1990 to 2009.

Selection criteria:

Randomized and quasi-randomized controlled trials of intravenous midazolam infusion in infants less than or equal to 28 days of age for sedation were selected for review.

Data collection and analysis:

Data regarding the primary outcome of level of sedation were abstracted. Secondary outcomes such as intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), death, length of NICU stay, and adverse effects associated with midazolam were assessed. When appropriate, meta-analyses were performed using relative risk (RR), risk difference (RD), along with their 95% confidence intervals (95% CI) for categorical variables and weighted mean difference (WMD) for continuous variables.

Main results:

Three trials were included in the review. Using different sedation scales, each study showed a statistically significantly higher sedation level in the midazolam group compared to the placebo group. However, since none of the sedation scales used have been validated in preterm infants, the effectiveness of midazolam in this population could not be ascertained. One study showed a statistically significant higher incidence of adverse neurologic events (death, grade III-IV IVH, PVL), and meta-analysis of data from two studies showed a statistically significant longer duration of NICU stay in the midazolam group compared to the placebo group.

Authors' conclusions:

There are insufficient data to promote the use of intravenous midazolam infusion as a sedative for neonates undergoing intensive care. This review raises concerns about the safety of midazolam in neonates. Further research on the effectiveness and safety of midazolam in neonates is needed.

This record should be cited as:

Ng E, Taddio A, Ohlsson A. Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD002052. DOI: 10.1002/14651858.CD002052

Assessed as up to date:

September 9, 2009

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Primary Review Group:

Neonatal Group

Health topics:

Neonatal care > Pain control

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit

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