| Study characteristics |
| Methods |
Single‐centre randomised double‐blind placebo‐controlled trial |
| Participants |
20 preterm infants (26 to 36 weeks), > 1000 grams birth weight, undergoing mechanical ventilation for respiratory distress syndrome, with indwelling arterial catheter
Exclusion criteria: any analgesic, sedating agent or muscle relaxant given before informed consent could be obtained |
| Interventions |
Fentanyl group (n = 11): loading dose 5 mcg/kg over 20 minutes followed by continuous infusion of 2 mcg/kg/hour for 72 hours, 1 mcg/kg/hour for the next 24 hours, and 0.5 mcg/kg/hour for the final 24 hours (total: 5 days)
Placebo group (n = 9): dextrose 5% in water |
| Outcomes |
Behavioral score; vital signs every 2 hours; cortisol and 11‐deoxycortisol levels at baseline and daily 3‐methyl histidine/urinary creatinine ratio and urea excretion (as indicators of catabolism); incidence of intraventricular haemorrhage; patent ductus arteriosus; bronchopulmonary dysplasia; sepsis |
| Notes |
Data on pain and on incidence of CLD and IVH 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 |
Randomisation was performed in the pharmacy by random number generation (not otherwise specified) |
| 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 |
