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

Jiang 2012.

Study characteristics
Methods Single‐centre randomised controlled double‐blind trial
Participants 46 full‐term or premature neonates who required MV were recruited
Exclusion criteria: history of severe asphyxia and hypoxia (5‐minute Apgar score < 4, umbilical blood pH < 7.0); severe intraventricular haemorrhage; severe congenital malformation (e.g. congenital heart disease, diaphragmatic hernia, cleft palate); paralysis; history of use of neuromuscular blocker agents
Interventions Morphine group (n = 22): i.v. infusion (> 1 hour) of 5% glucose‐saline 10 mL + morphine 100 mcg/kg, followed by continuous i.v. infusion of 5% glucose‐saline 24 mL + morphine 10 mcg/kg/hour for several days until criteria for withdrawal were met
Control group (n = 24): i.v. infusion (> 1 hour) of 5% glucose‐saline 10 mL, followed by continuous i.v. infusion of 5% glucose‐saline 24 mL for several days until criteria for withdrawal were met
Outcomes Respiratory rate (RR); peak inspiratory pressure (PIP); positive end‐expiratory pressure (PEEP); fraction of inspired oxygen (FiO₂); mean arterial pressure (MAP); heart rate (HR).
Pain assessment by N‐PASS score and COMFORT score was measured at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after administration; brain ultrasound was done at Day 1 (before administration), 5, 7, and 14. Total ventilation time, total time from withdrawal to extubation, total oxygen time after ventilation, and adverse events were evaluated
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done with 15 sets of opaque envelopes containing 4 cards reporting A or B (A = intervention; B = control). A member of the research group took out a random card from a random set for each newborn included
Allocation concealment (selection bias) Low risk Envelopes were opaque
Blinding of participants and personnel (performance bias) Low risk The nurse knew only the meaning of "A" and "B" as intervention or control and labelled drugs so they were not different in volume, appearance, and odour  
Blinding of outcome assessment (detection bias) Low risk Assessors were blinded to treatment
Incomplete outcome data (attrition bias) Low risk All infants were accounted for
Selective reporting (reporting bias) Unclear risk Trial not registered; protocol not available
Not reported in results: total ventilation time, total time from withdrawal to extubation, total oxygen time after ventilation, brain ultrasound
Other bias Low risk Study appears to be free of other sources of bias