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 |
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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 |