Togrul 2011.
Methods | Double‐blind, random allocation to IV paracetamol 30 min before surgery versus IV tramadol 20 min before end of surgery | |
Participants | Type of surgery: septo‐rhinoplasty Paracetamol group Entered/completing: 25/25 Age (mean, SD): 31.5 ± 11 Sex (male, %): 64 Tramadol group Entered/completing: 25/25 Age (mean, SD): 31.8 ± 10 Sex (male, %): 64 |
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Interventions | Paracetamol infusion 1 g given 30 min before end of surgery IV tramadol given 30 min (in abstract written 20 min) before end of surgery, dose not stated. In abstract ‐ 1 mg/kg dose is mentioned. |
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Outcomes | Primary: Pain intensity on 10 cm VAS Secondary: Patient satisfaction, drug side effects, analgesic need |
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Source of funding | Not stated | |
Were treatment groups comparable at baseline? | Yes: age, sex, weight, duration of surgery, and anesthesia | |
Details of preoperative pain | Not reported | |
Notes | Postoperatively participants could take 500 mg oral paracetamol, up to 3 g/day, and if required, tramadol 0.5 mg/kg as IV bolus | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Last paragraph of introduction states it was double‐blind but no additional details were provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants have completed |
Selective reporting (reporting bias) | High risk | Objective state adverse effect and patient satisfaction investigation. Adverse effect not reported. Only nausea % in one group is reported, stating it is higher than in the other group, but no quantitative data. Patient satisfaction not reported. |
Size | High risk | Fewer than 50 participants per arm of the study (25 paracetamol, 25 tramadol) |