Methods | Randomized controlled trial | |
Participants | 2‐6 years, elective fibreoptic bronchoscopy Exclusion criteria: haemoptysis, previous fibreoptic bronchoscopy Recruitment: 50 children (25 in each group) Location: Turkey | |
Interventions | Remifentanil 1 mcg/kg bolus over 2 minutes, then infusion 0.15 mcg/kg/min Control group: no remifentanil All participants: premedication with oral midazolam 0.5 mg/kg and nebulized 4% lignocaine 4 mg/kg, sevoflurane induction and maintenance in 100% oxygen, IV access after induction, then given IV atropine 10 mcg/kg | |
Outcomes | EA defined as a score ≥ 4 on the following scale: 1 = sleeping 2 = awake, calm and cooperative 3 = crying, requiring consoling 4 = irritable/restless, screaming, inconsolable 5 = combative, disoriented, thrashing Measured at emergence, 5, 10, 15 minutes Other outcomes: thoracic wall rigidity during bolus, coughing, emergence and recovery times | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized by sealed envelope," method of random sequence generation not stated |
Allocation concealment (selection bias) | Low risk | "sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | child blinded, anaesthetist not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "persons scoring the children for agitation and cough were unaware of group allocation" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | no withdrawals |
Selective reporting (reporting bias) | Low risk | reported incidence of EA |