Akarsu 2010.
Methods | Randomized, double‐blind, parallel, active‐controlled. Pain evaluated up to 6 h after dose administered. | |
Participants | Type of surgery: cesarean section Paracetamol group Entered/completing: 40/unclear Age (mean, SD): 24.2 ± 1.1 Sex (male, %): 0 Control group Entered/completing: 40/unclear Age (mean, SD): 24.4 ± 1.2 Sex (male, %): 0 |
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Interventions | Paracetamol 1 g IV over 15 min at first complaint of pain Diclofenac 75 mg IM as above |
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Outcomes | Primary: time to first rescue analgesic (1 mg/kg IM pethidine) Secondary: VAS pain scores at 30 min, 1, 2, 4 and 6 h; adverse events |
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Source of funding | Not reported | |
Were treatment groups comparable at baseline? | Yes ‐ all P values > 0.05: demographic characteristics, week of pregnancy, newborn's weight, Apgar scores, operation time, time to first postoperative analgesic requirement | |
Details of preoperative pain | Participants with previous continuous analgesic use were excluded | |
Notes | Translated from Turkish using Google Translate | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Used envelopes to randomly divide 2 groups – no additional details given |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details but stated as double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No mention of participants dropping out |
Selective reporting (reporting bias) | Low risk | All outcomes in Methods section reported in Results |
Size | High risk | Fewer than 50 participants per arm of the study (40 paracetamol, 40 diclofenac) |