Midazolam sedation in mechanically ventilated newborns: a double blind randomized placebo controlled trial.
OBJECTIVE
To determine efficacy of midazolam as a sedative in mechanically ventilated newborns.


METHODS
Double blind randomized placebo controlled trial.


METHODS
Neonatal Unit of Tertiary Hospital.


RESULTS
Sedation over 48 h of observation.


METHODS
Neonates with birth weight less than 2000 g who were mechanically ventilated within 7 days of life were randomly assigned to midazolam and placebo group. Midazolam and placebo were administered as bolus (0.2 mg/kg) followed by continuous infusion (0.06 mg/kg/h). Both groups received morphine infusion (10 microg/kg/h). Sedation score was noted at 6 hourly intervals for 48 hours. Hemodynamic variables, ventilatory variables, complications and side effects of treatments were also recorded.


RESULTS
Thirty-three neonates were enrolled (17 in midazolam, 16 in placebo group). The groups were comparable for birth weights and gestation. The midazolam group had significantly better sedation from 18-24 hours after enrollment compared to placebo group. At 48 h there were no significant differences in proportion of infants with adequate sedation between midazolam and placebo group. The two groups were comparable with respect to heart rate, perfusion, ventilatory indices and blood gas parameters. None of the infants were noted to have hypotension on loading with midazolam or placebo. Seizures were noted in 2 neonates in placebo group 24 hours after enrollment (insignificant statistically).


CONCLUSIONS
Sedation provided by continuous infusion of midazolam and morphine appears to be comparable to morphine alone in newborn babies on mechanical ventilation, with no significant adverse effects. The course of mechanical ventilation is not influenced by use of midazolam.
Arya
V
V
Neonatal Division, Department of Pediatrics, Maulana Azad Medical College, New Delhi 110 002, India.
Ramji
S
S
D016292:Procedural Sedation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D008874:Midazolam; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000628:therapy*; D012772:Shock, Septic / Q000628:therapy*; D016896:Treatment Outcome
D008874:Midazolam