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Meta-Analysis
. 2024 May 2;5(5):CD012361.
doi: 10.1002/14651858.CD012361.pub2.

Dexmedetomidine for analgesia and sedation in newborn infants receiving mechanical ventilation

Jia Yi Lim  1 , Chin Jin Ker  1 , Nai Ming Lai  2 , Olga Romantsik  3 , Michelle Fiander  4 , Kenneth Tan  1   5
Affiliations
Meta-Analysis

Dexmedetomidine for analgesia and sedation in newborn infants receiving mechanical ventilation

Jia Yi Lim et al. Cochrane Database Syst Rev. .

Abstract

Background: Dexmedetomidine is a selective alpha-2 agonist with minimal impact on the haemodynamic profile. It is thought to be safer than morphine or stronger opioids, which are drugs currently used for analgesia and sedation in newborn infants. Dexmedetomidine is increasingly being used in children and infants despite not being licenced for analgesia in this group.

Objectives: To determine the overall effectiveness and safety of dexmedetomidine for sedation and analgesia in newborn infants receiving mechanical ventilation compared with other non-opioids, opioids, or placebo.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, and two trial registries in September 2023.

Selection criteria: We planned to include randomised controlled trials (RCTs) and quasi-RCTs evaluating the effectiveness of dexmedetomidine compared with other non-opioids, opioids, or placebo for sedation and analgesia in neonates (aged under four weeks) requiring mechanical ventilation.

Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were level of sedation and level of analgesia. Our secondary outcomes included days on mechanical ventilation, number of infants requiring additional medication for sedation or analgesia (or both), hypotension, neonatal mortality, and neurodevelopmental outcomes. We planned to use GRADE to assess the certainty of evidence for each outcome.

Main results: We identified no eligible studies for inclusion. We identified four ongoing studies, two of which appear to be eligible for inclusion; they will compare dexmedetomidine with fentanyl in newborn infants requiring surgery. We listed the other two studies as awaiting classification pending assessment of full reports. One study will compare dexmedetomidine with morphine in asphyxiated newborns undergoing hypothermia, and the other (mixed population, age up to three years) will evaluate dexmedetomidine versus ketamine plus dexmedetomidine for echocardiography. The planned sample size of the four studies ranges from 40 to 200 neonates. Data from these studies may provide some evidence for dexmedetomidine efficacy and safety.

Authors' conclusions: Despite the increasing use of dexmedetomidine, there is insufficient evidence supporting its routine use for analgesia and sedation in newborn infants on mechanical ventilation. Furthermore, data on dexmedetomidine safety are scarce, and there are no data available on its long-term effects. Future studies should address the efficacy, safety, and long-term effects of dexmedetomidine as a single drug therapy for sedation and analgesia in newborn infants.

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Conflict of interest statement

JYL has declared that they have no conflict of interest. CJK has declared that they have no conflict of interest. NML is an Associate Editor at Cochrane Clinical Answers, an Associate Editor at Cochrane Neonatal, and a Sign‐off Editor at Cochrane Central Editorial Services, but was not involved in the editorial process for this review. OR has declared that they have no conflict of interest. MF is a Managing Editor and Information Specialist for Cochrane Neonatal, but was not involved in the editorial acceptance or assessment of this review. KK has declared that they have no conflict of interest. Dr Masitah Ibrahim has declared that they have no conflict of interest.

Figures

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PRISMA flow diagram.
See this image and copyright information in PMC

Update of

References

References to studies excluded from this review

Cai 2013 {published data only}
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CTRI/2020/02/023636 {published data only}
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CTRI/2021/03/031988 {published data only}
    1. CTRI/2021/03/031988. A study to compare the efficacy of dexmedetomidine and midazolam for sedation of mechanically ventilated children [Dexmedetomidine versus midazolam as a primary sedative in mechanically ventilated children: a randomized controlled trial]. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2021/03/031988 (first received 15 March 2021). [CENTRAL: CN-02256612]
EUCTR2006‐004836‐61‐GB {published data only}
    1. EUCTR2006-004836-61-GB. Dexmedetomidine as a sedative in paediatric intensive care. Dexmedetomidine in PICU. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2006-004836-61-GB (first received 9 October 2006). [CENTRAL: CN-01879885]
EUCTR2015‐002114‐80‐IT {published data only}
    1. EUCTR2015-002114-80-IT. Efficacy and safety of dexmedetomidine during weaning from analgesia and sedation in pediatric intensive care unit. A multicenter, double-blind, randomized controlled trial. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2015-002114-80-IT (first received 2 February 2019). [CENTRAL: CN-01946368]
Grant 2016 {published data only}
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IRCT20190114042358N2 {published data only}
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ISRCTN11031435 {published data only}
    1. ISRCTN11031435. Anaesthesia with dexmedetomidine and fentanyl for surgery in newborn babies [Anaesthesia with dexmedetomidine and fentanyl for neonatal surgery: a pilot study]. trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN11031435 (first received 10 January 2017). [CENTRAL: CN-01822831]
Li 2016 {published data only}
    1. Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, et al. A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia 2016;71(5):522-28. [DOI: 10.1111/anae.13407] [PMID: ] - DOI - PubMed
Li 2018 {published data only}
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Long 2018 {published data only}
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NCT02996058 {published data only}
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Prasad 2012 {published data only}
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Saleh 2016 {published data only}
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Tobias 2004 {published data only}
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References to studies awaiting assessment

ChiCTR‐IOR‐16009780 {published data only}
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NCT04772222 {published data only}
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References to ongoing studies

CTRI/2022/01/039656 {published data only}
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NCT05324891 {published data only}
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