Objective To compare the effectiveness of sedation by intranasal administration of midazolam (nMDZ) or ketamine (nKTM) for neonatal intubation.
Design A multicentre, prospective, randomised, double-blind study.
Setting Delivery rooms at four tertiary perinatal centres in France.
Patients Preterm neonates with respiratory distress requiring non-emergent endotracheal intubation for surfactant instillation.
Interventions Treatment was randomly allocated, with each neonate receiving a bolus of 0.1 mL/kg in each nostril, corresponding to 0.2 mg/kg for nMDZ and 2 mg/kg for nKTM. The drug was repeated once 7 min later at the same dose if adequate sedation was not obtained.
Main outcome measures Success was defined by adequate sedation before intubation and adequate comfort during the procedure. Intubation features, respiratory and cardiovascular events were recorded.
Results Sixty newborns, with mean (SD) gestational age and birth weight of 28 (3) weeks and 1100 (350) g, were included within the first 20 min of life. nMDZ was associated with a higher success rate (89% vs 58%; RR: 1.54, 95% CI 1.12 to 2.12, p<0.01) and shorter delays between the first dose and intubation (10 (6) vs 16 (8) min, p<0.01).
Number of attempts, time to intubation, mean arterial blood pressure measures over the first 12 hours after birth and length of invasive ventilation were not different.
Conclusions nMDZ was more efficient than nKTM to adequately sedate neonates requiring intubation in the delivery room. The haemodynamic and respiratory effects of both drugs were comparable.
Clinical trial This clinical trial was recorded on the National Library of Medicine registry (NCT01517828).
- nasal mucosa
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Contributors CM, JB and GC conceptualised and designed the study, drafted the initial manuscript and approved the final manuscript as submitted. TM and CéC carried out the initial analyses, reviewed and revised the manuscript and approved the final manuscript as submitted. FB-C, FF, GT and PT coordinated and supervised data collection in their investigation site, critically reviewed the manuscript and approved the final manuscript as submitted. RC critically reviewed the manuscript and approved the final manuscript as submitted. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding All phases of this study were supported by Montpellier University Hospital (Grant: Appel d'Offre Interne 2011). Role of the Funders/Sponsors: The funders/sponsors had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent Parental/guardian consent obtained.
Ethics approval South mediterranean IV ethics committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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