Arslan 2013.
Methods | Randomized, placebo‐controlled, single dose, over 24 h Interventions administered preemptively (not included in this review) or at end of surgery |
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Participants | Type of surgery: elective lap cholecystectomy Paracetamol group Entered/completing: 100/100 Age (mean, SD): 41.5 ± 7.8 Sex (male, %): 32 Control group Entered/completing: 100/100 Age (mean, SD): 44.5 ± 6.5 Sex (male, %): 34 |
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Interventions | Paracetamol 1 g/100 ml IV over 10 min Placebo: saline as above |
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Outcomes | Primary: time to first rescue dose and cumulative amount of rescue analgesic (tramadol 100 mg IV for VAS pain score > 4, up to 400 mg max) Secondary: VAS pain scores at several time points up to 24 h, numbers of participants in each group requiring rescue medication within various postoperative intervals and cumulatively, adverse events, patient satisfaction at 24 h (0 = poor to 4 = excellent) |
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Source of funding | No funding | |
Were treatment groups comparable at baseline? | Yes | |
Details of preoperative pain | None – participants with history of usage of paracetamol, opioids, or NSAIDs for 3 months were excluded | |
Notes | Third group receiving paracetamol preemptively not included in this review. All participants received fentanyl 1 µg/kg at induction of anesthesia, which had a total duration of about 100 min in all groups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | It appears that all participants completed the study and contributed data for each outcome at all relevant time points |
Selective reporting (reporting bias) | Low risk | All outcomes from Methods section reported in Results section |
Size | Unclear risk | 50 to 199 participants per arm of the study (100 paracetamol, 100 placebo) |