| Study characteristics |
| Methods |
Single‐centre randomised controlled trial |
| Participants |
30 newborns (28 to 39 weeks) mechanically ventilated longer than 24 hours, with disease including neonatal pneumonia, neonatal respiratory distress syndrome, neonatal aspiration pneumonia, and neonatal wet lung
Exclusion criteria: not stated |
| Interventions |
Fentanyl group (n = 15): 2 mcg/kg by intravenous bolus injection (bolus time > 10 minutes), followed by continuous intravenous infusion (2 mcg/kg/hour; dose was adjusted according to degree of pain in the patient)
Control group (n = 15): no intervention |
| Outcomes |
Heart rate; respiratory rate; blood pressure; percutaneous oxygen saturation; PIPP score recorded before treatment and at 30 minutes, 2 hours, and 4 hours after drug administration
Mental development index (MDI) and psychomotor development index (PDI) were measured using the CDCC intellectual development scale for infants, during follow‐up at 3, 6, 9, and 12 months after discharge |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random sequence generation is not specified |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment is not specified |
| Blinding of participants and personnel (performance bias) |
High risk |
Unblinded intervention |
| Blinding of outcome assessment (detection bias) |
Unclear risk |
Blinding of outcome assessment is not specified |
| Incomplete outcome data (attrition bias) |
Low risk |
All infants are accounted for |
| Selective reporting (reporting bias) |
Unclear risk |
We could not ascertain if there were deviations from the original protocol in the final publication (trial not registered, protocol not available) |
| Other bias |
Low risk |
Study appears to be free of other sources of bias |
