Beaussier 2005.
Methods | Randomized, double‐blind, double‐dummy, active‐controlled Medications administered at the beginning of wound closure |
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Participants | Type of surgery: inguinal hernia repair Propacetamol group Entered/completing: 90/90 Age (mean, SD): 46 ± 14 Sex (male, %): 94 Parecoxib group Entered/completing: 92/90 Age (mean, SD): 42 ± 14 Sex (male, %): 91 |
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Interventions | Intervention: 2 g propacetamol over 15 min Control: parecoxib 40 mg IV |
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Outcomes | Primary: opioid consumption (morphine) Pain intensity at rest and while coughing (VRS, VAS) and derived summary measures |
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Source of funding | Pfizer SA | |
Were treatment groups comparable at baseline? | Yes: intraoperative opioid consumption and time to tracheal extubation did not differ between groups; demographics (age, sex, weight, height) similar | |
Details of preoperative pain | Patients with chronic pain excluded | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization performed centrally as blocks of 4 and with a 2:2 treatment ratio. In each center, treatment allocation was performed on the basis of one complete treatment block. |
Allocation concealment (selection bias) | Low risk | Central allocation |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐dummy design employed. Propacetamol was administered by slow infusion over 15 min whereas parecoxib was injected by rapid bolus. Each participant received both an active product and the placebo of the other product. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | For primary outcome, data reported for both modified‐ITT population and per‐protocol population. Secondary outcomes reported data for ITT population. |
Selective reporting (reporting bias) | Low risk | All outcomes reported with mean data or raw numbers |
Size | Unclear risk | 50 to 199 participants per arm of the study (90 propacetamol, 92 parecoxib) |