Hynes 2006.
Methods | Randomized, double‐blinded, double‐dummy, placebo‐ and active‐controlled Medication administered on postoperative day 1, when baseline pain reached moderate‐to‐severe intensity |
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Participants | Type of surgery: total hip arthroplasty Propacetamol group Entered/completing: 40/40 Age (mean, SD): 65.7 ± 9.8 Sex (male, %): 40 Diclofenac group Entered/completing: 40/40 Age (mean, SD): 65.6 ± 7.6 Sex (male, %): 55 Placebo group Entered/completing: 40/40 Age (mean, SD): 66.1 ± 7.1 Sex (male, %): 45 |
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Interventions | Intervention: 2 g propacetamol IV Control: 75 mg diclofenac IM Placebo: double‐dummy not described |
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Outcomes | Pain intensity (VRS, VAS) Pain relief (categorical) Time to request for rescue medication Global assessment (categorical) |
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Source of funding | Supported by Bristοl‐Myers Squibb | |
Were treatment groups comparable at baseline? | Yes: demographics; duration of anesthesia; baseline postoperative pain | |
Details of preoperative pain | Not reported | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐dummy technique employed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 11/40 missing pain assessment data at 5 h in intervention group due to lack of efficacy and administration of rescue dose (29/40 in placebo group), but all 40 included in efficacy analysis. Data were imputed using LOCF. |
Selective reporting (reporting bias) | Unclear risk | All outcomes from Methods section reported in Results section, but time to rescue was instead reported as number of participants requesting rescue |
Size | High risk | Fewer than 50 participants per arm of the study (40 propacetamol, 40 diclofenac, 40 placebo) |