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. 2021 Mar 17;2021(3):CD013732. doi: 10.1002/14651858.CD013732.pub2

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
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