Faiz 2014.
Methods | Randomized, double‐blind, active‐controlled. Evaluated up to 24 h after surgery. Medications administered prior to skin closure |
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Participants | Type of surgery: elective abdominal hysterectomy Paracetamol group Entered/completing: 40/40 Age (mean, SD): 49.9 ± 6.9 Sex (male, %): 0 Control group Entered/completing: 40/40 Age (mean, SD): 47.2 ± 7.2 Sex (male, %): 0 |
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Interventions | Paracetamol 15 mg/kg in 100 ml NS, single dose over 15 min Ketamine 0.15 mg/kg administered as above |
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Outcomes | Primary: pain (VAS 0 to 10) in recovery room and at 4, 6, 12 and 24 h postop Secondary: sedation (Ramsay scale), adverse events (nausea, vomiting, respiratory complications, hemodynamic changes), rescue analgesia (pethidine 15 mg for VAS pain > 3) |
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Source of funding | Iran University of Medical Sciences | |
Were treatment groups comparable at baseline? | Yes: demographics and duration of surgery | |
Details of preoperative pain | Not reported, but participants currently using opioids were excluded | |
Notes | Low dose of ketamine used in comparator group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding (performance bias and detection bias) All outcomes | Low risk | “Both medication solutions were prepared by the research pharmacist in 100 ml of normal saline and were administered by the anesthesia care team within a 15‐minute time period. The administering team was blinded to the nature of the infusate”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts; tables suggest that all participants reported data |
Selective reporting (reporting bias) | Low risk | All planned primary and secondary outcomes reported, although total amount of rescue analgesia not reported. Confirmed on trials registry (http://www.irct.ir/searchresult.php?id=11319&number=1). |
Size | High risk | Fewer than 50 participants per arm of the study (40 paracetamol, 40 ketamine) |