| Study characteristics |
| Methods |
Single‐centre double‐blind randomised controlled trial |
| Participants |
20 neonates were enrolled according to the inclusion criteria: preterm neonates (28 to 34 weeks) with clinical and radiological features compatible with RDS, requiring elective tracheal intubation and surfactant therapy
Exclusion criteria: major congenital malformations; birth weight < 1000 g; previous or concurrent use of opioid for any reason; haemodynamic instability before indication of tracheal intubation; volume expansion need |
| Interventions |
Remifentanil group (n = 10): continuous infusion of 0,5 mcg/kg/min
Morphine group (n = 10): continuous infusion of 10 mcg/kg/hour
Both infusions began 15 minutes after successful intubation. If extubation was possible (gas results were normal, and there was no other concomitant event to contraindicate extubation), continuous drug infusion was stopped |
| Outcomes |
Primary outcome: time to awaken and time to extubate after interruption of opioid administration. The presence of open eyes, limb movements, and individual respiratory incursions defined awake
Secondary outcomes: level of pain (NIPS Scale, COMFORT Scale); HR; BP; temperature; SpO₂; continuous positive airway pressure (CPAP) therapy duration |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A random number table was used to randomise premature neonates |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not stated |
| Blinding of participants and personnel (performance bias) |
Low risk |
Carers were blinded |
| Blinding of outcome assessment (detection bias) |
Low risk |
Assessors were blinded |
| Incomplete outcome data (attrition bias) |
Low risk |
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 |
