Dyke 1995.
Study characteristics | ||
Methods | Single‐centre randomised double‐blind placebo‐controlled trial | |
Participants | 26 preterm infants (29 to 36 weeks) requiring mechanical ventilation for hyaline membrane disease Exclusion criteria: major congenital malformations |
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Interventions | Morphine group (n = 12): loading dose 100 mcg/kg over 30 minutes followed by continuous infusion 10 mcg/kg/hour Placebo group (n = 14): dextrose 5% Infusion continued until weaning from intermittent mandatory ventilation, or for maximum of 48 hours' therapy. Pancuronium allowed for infants not stabilised by ventilatory adjustment and markedly asynchronous with the ventilator (2/12 infants in morphine group, 3/14 in the placebo group) | |
Outcomes | Primary outcomes: heart rate, blood pressure, respiratory rate hourly; severity of respiratory distress; interaction of the infant with positive‐pressure ventilation Secondary outcomes: duration of oxygen therapy; ventilator therapy and hospitalisation; incidence of bronchopulmonary dysplasia, periventricular haemorrhage, and pneumothorax | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed by a computer‐generated list in the pharmacy |
Allocation concealment (selection bias) | Low risk | Allocation concealment was adequate |
Blinding of participants and personnel (performance bias) | Low risk | Caregivers were blinded to treatment |
Blinding of outcome assessment (detection bias) | Low risk | Assessors were blinded to treatment |
Incomplete outcome data (attrition bias) | Low risk | There was no loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Trial not registered; protocol not available |
Other bias | Low risk | Study appears to be free of other sources of bias |