Midazolam sedation in mechanically ventilated newborns: A double blind randomized placebo controlled trial

To determine efficacy of midazolam as a sedative in mechanically ventilated newborns. Double blind randomized placebo controlled trial. Neonatal Unit of Tertiary Hospital. Sedation over 48 h of observation. Neonates with birth weight less than 2000 g who were mechanically ventilated within 7 days of...

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Bibliographic Details
Published in:Indian pediatrics 2001-09, Vol.38 (9), p.967-972
Main Authors: ARYA, Vishal, RAMJI, Siddarth
Format: Article
Language:English
Subjects:
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Conscious Sedation
Digestive system
Double-Blind Method
Emergency and intensive care: neonates and children. Prematurity. Sudden death
Female
Humans
India
Infant, Newborn
Intensive care medicine
Intensive Care Units, Neonatal
Male
Medical sciences
Midazolam
Pharmacology. Drug treatments
Respiration, Artificial
Respiratory Distress Syndrome, Newborn - therapy
Shock, Septic - therapy
Treatment Outcome
Tropical medicine
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Summary:To determine efficacy of midazolam as a sedative in mechanically ventilated newborns. Double blind randomized placebo controlled trial. Neonatal Unit of Tertiary Hospital. Sedation over 48 h of observation. 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. 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). 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.
ISSN:0019-6061
0974-7559