| Study characteristics |
| Methods |
Single‐centre randomised double‐blind placebo‐controlled trial |
| Participants |
31 preterm infants (> 28 weeks to < 37 weeks) ventilated for hyaline membrane disease
Exclusion criteria: not stated |
| Interventions |
Fentanyl group (n = 15): continuous infusion of 1.5 mcg/kg/hour scaled down by 0.5 mcg/kg/hour every 24 hours, for a total of 72 hours
Placebo group (n = 16): 5% glucose |
| Outcomes |
Ventilator setting; sedation score (not described) every 4 hours; severity of respiratory disorder; radiological score; duration of ventilation; need for surfactant therapy; duration of oxygen dependence; electromyographic activity of intercostal muscles |
| Notes |
Data, methods, and details were obtained by personal communication with the study author |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method of randomisation was not stated |
| Allocation concealment (selection bias) |
Low risk |
The use of sealed envelopes was reported (study author's communication) |
| Blinding of participants and personnel (performance bias) |
Low risk |
Caregivers were unaware of treatment |
| Blinding of outcome assessment (detection bias) |
Low risk |
Assessors were stated to be blinded to treatment |
| Incomplete outcome data (attrition bias) |
Unclear risk |
All infants were accounted for. However, as the study is available as an abstract only, risk for attrition bias is unclear |
| 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 |
