Document Detail

Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit.
MedLine Citation:
PMID:  22696328     Owner:  NLM     Status:  MEDLINE    
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 or physiological measurements, or both, for critically ill neonates undergoing intensive care and to assess clinically significant short- and long-term adverse effects associated with its use.
SEARCH METHODS: We performed a literature search according to the Cochrane Neonatal Review Group search strategy. Randomised and quasi-randomised controlled trials of intravenous midazolam use in neonates were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2012), MEDLINE (1985 to 2012), EMBASE (1980 to 2012), CINAHL (1981 to 2012), reference lists of published studies, personal files, and abstracts published in The Pediatric Academic Societies Meeting Abstract Archives from 1990 to 2011.
SELECTION CRITERIA: Randomised and quasi-randomised controlled trials of intravenous midazolam infusion in infants aged 28 days or less 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 haemorrhage (IVH), periventricular leukomalacia (PVL), death, length of NICU stay, and adverse effects associated with midazolam were assessed. When appropriate, meta-analyses were performed using risk ratio (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 neurological events (death, grade III or 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.
Eugene Ng; Anna Taddio; Arne Ohlsson
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Review     Date:  2012-06-13
Journal Detail:
Title:  The Cochrane database of systematic reviews     Volume:  6     ISSN:  1469-493X     ISO Abbreviation:  Cochrane Database Syst Rev     Publication Date:  2012  
Date Detail:
Created Date:  2012-06-14     Completed Date:  2012-08-13     Revised Date:  2013-06-28    
Medline Journal Info:
Nlm Unique ID:  100909747     Medline TA:  Cochrane Database Syst Rev     Country:  England    
Other Details:
Languages:  eng     Pagination:  CD002052     Citation Subset:  IM    
Aubrey andMarla Dan ProgramforHigh RiskMothers and Babies, SunnybrookHealth Sciences Centre, Toronto, Canada.
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MeSH Terms
Hypnotics and Sedatives / administration & dosage*,  adverse effects
Infant, Newborn
Infusions, Intravenous
Intensive Care Units, Neonatal
Intensive Care, Neonatal
Midazolam / administration & dosage*,  adverse effects
Randomized Controlled Trials as Topic
Reg. No./Substance:
0/Hypnotics and Sedatives; 59467-70-8/Midazolam
Update Of:
Cochrane Database Syst Rev. 2003;(1):CD002052   [PMID:  12535424 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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