| Study characteristics |
| Methods |
Single‐centre randomised double‐blind trial |
| Participants |
20 term neonates (≥ 37 weeks) mechanically ventilated longer than 24 hours were included
Exclusion criteria: known allergy to fentanyl or sufentanil; renal or hepatic dysfunction (serum creatinine > 1.5 mg/dL, urinary production < 0.5 mL/(kg × hour) after 48 hours; glutamate‐oxaloacetate‐transferase (GOT) > 150 U/L, Quick < 25%); maternal history of prenatal opioid abuse; chromosomal disorders; major anomalies |
| Interventions |
Fentanyl group (n = 10): intravenous loading dose of 2 to 3 μg/kg in 15 minutes, followed by maintenance rate of 1 μg/(kg × hour)
Sufentanil group (n = 10): intravenous loading dose of 0.28 to 0.42 μg/kg in 15 minutes, followed by maintenance rate of 0.14 μg/(kg × hour)
In case of inadequate analgesia (estimated by the Hartwig Behavioural Pain Scale score), opioid dose was adjusted in steps of 0.5 to 1 μg/(kg × hour) fentanyl or 0.07 to 0.14 μg/(kg × hour) sufentanil according to flow rate. Administration of an additional bolus equal to a 2‐hour maintenance infusion dose was possible. As sedative, co‐medication midazolam was allowed |
| Outcomes |
Primary outcome: duration of weaning, defined as time to extubation after opioid discontinuation
Secondary outcomes: SNAP score (Score for Neonatal Acute Physiology) within the first 24 hours; TISS (Therapeutic Intervention Scoring System) daily; behavioural analgesic and sedation scores (Hartwig score) every 4 hours; HR; ABP; oxygen saturation; diuresis; urinary cortisol levels; Quick value, GOT, and creatinine (daily); co‐medications; enteral/oral feeding; withdrawal symptoms (Finnegan score); duration of MV also measured |
| Notes |
Power calculation was made on the duration of weaning |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomisation by concealed envelops in blocks of 4 patients. Sequence generation not specified |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not specified |
| Blinding of participants and personnel (performance bias) |
Low risk |
Doctors as well as nurses were blinded with respect to medication |
| Blinding of outcome assessment (detection bias) |
Low risk |
Doctors as well as nurses were blinded with respect to medication |
| Incomplete outcome data (attrition bias) |
Unclear risk |
Tables 1 and 2 report 10 patients for each group, whereas in the Methods, it is reported (quote): "comparison of weaning time at the interim analysis (intention‐to‐treat population n = 13, fentanyl n = 6, and sufentanil group = 7)" |
| Selective reporting (reporting bias) |
Unclear risk |
All outcomes reported; protocol not available |
| Other bias |
Low risk |
Study appears to be free of other sources of bias |
