Ionides 1994.
Study characteristics | ||
Methods | Single‐centre randomised controlled trial | |
Participants | Infants mechanically ventilated who required the use of pancuronium and/or morphine or fentanyl, according to the attending physician's judgement, were included Exclusion criteria: asphyxia (Apgar score ≤ 3 at 5 minutes); foetal drug exposure; sepsis; major congenital anomalies Among the 27 neonates enrolled, 2 were excluded because of inadequate blood sampling, 3 received only pancuronium, and the remaining 22 were randomly assigned to fentanyl or morphine | |
Interventions | Fentanyl group (n = 10): 3 mcg/kg as a single intravenous dose Morphine group (n = 12): 0.1 mg/kg as a single intravenous dose 4 newborns in the fentanyl group and 2 in the morphine group received both pancuronium and opioid; pancuronium was always administered first, followed by opiate in 1 hour | |
Outcomes | β‐Endorphin concentration before and 1 hour after administration of each medicine; HR; systolic and diastolic BP | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Patients were assigned by medical record number |
Allocation concealment (selection bias) | High risk | The chosen sequence did not allow for allocation concealment |
Blinding of participants and personnel (performance bias) | Unclear risk | Blinding was not clearly ensured |
Blinding of outcome assessment (detection bias) | Unclear risk | Blinding was not clearly ensured |
Incomplete outcome data (attrition bias) | Low risk | All infants accounted for 2 infants subsequently excluded because of inadequate blood sampling |
Selective reporting (reporting bias) | Unclear risk | Trial not registered; protocol not available |
Other bias | Unclear risk | The randomisation process between morphine and fentanyl groups was started after the attending physician decided whether to use pancuronium, opiates, or both |