Methods |
Randomized double‐blind controlled trial. Leicester Royal Infirmary, Leicester, UK |
Participants |
40 pregnant women. Age: 16‐40 years. ASA I and II. Gestational week up to 12 weeks. Exclusion criteria: history of asthma, drug allergy or sensitivity to opioids. |
Interventions |
Group 1: nalbuphine 0.25 mg/kg IV.
Group 2: fentanyl 1.5mcg/kg IV.
All participants: No premedication.
One minute after opioid anesthesia was induced in both groups with thiopentone 3‐4mg/kg. Maintenance with Bain breathing system with 66% nitrous oxide in oxygen and supplementation with enflurane as needed. Syntocinon 10units IV at onset of cervical dilation. Postoperative analgesia with paracetamol 1g orally 6 hourly. |
Outcomes |
Postoperative pain reported on a 10cm horizontal linear analog scale at 1, 2 and 4 hours postoperatively.
Duration of anesthesia, dose of thiopentone, and maximum concentration of enflurane administration. Time until recovery of consciousness (name, date of birth and correct address) and psychomotor function. Patient assessment as asleep, awake, and calm or awake and restless on four different occasions (pre‐operatively, 1, 2, and 4 hours postoperatively). Postoperative nausea. Need for postoperative analgesics. |
Notes |
No power calculations. Unclear study length, method of randomization and allocation concealment. Unclear if the procedure was vacuum versus sharp curettage. The author could not be succeessfully contacted to clarify unclear information.
Outcome assessor in recovery room was blinded. No major complication reported. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |