Sinatra 2005.
| Methods | Randomized, double‐blind, double‐dummy, placebo‐controlled Medications administered on postoperative day 1, when baseline pain reached moderate‐to‐severe intensity (after PCA disconnected) |
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| Participants | Type of surgery: total hip arthroplasty Paracetamol group Entered/completing: 49/46 Age (mean, SD): 61.7 ± 16.9 Sex (male, %): 57 Propacetamol group Entered/completing: 50/44 Age (mean, SD): 59.5 ± 14.2 Sex (male, %): 54 Placebo group Entered/completing: 52/47 Age (mean, SD): 59.2 ± 13.4 Sex (male, %): 42 |
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| Interventions | Intervention: 1 g IV paracetamol in 100 ml solution over 15 min Control: 2 g propacetamol Placebo: 100 ml solution |
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| Outcomes | Primary: pain relief (VRS) Pain intensity (VAS, VRS) Time to rescue medication (morphine) Opioid consumption (morphine) Patient global evaluation |
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| Source of funding | Supported by Bristol‐Myers Squibb Company, Rueil‐Malmaison, France | |
| Were treatment groups comparable at baseline? | Yes: demographics, anesthetic and surgical procedure and baseline pain intensity | |
| Details of preoperative pain | "The overwhelming majority of patients had symptoms of severe debilitating or painful osteoarthritis". Not mentioned if this was similar between groups. | |
| Notes | — | |
| 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 described |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Unblinded pharmacist was not involved in the study. All study medications were administered as a 100 ml solution infused over 15 min. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | From a total of 156 randomized patients 151 included. "All of these 151 patients were included in the intent‐to‐treat population and analyzed for demographics, efficacy and safety". |
| 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 (49 paracetamol, 50 propacetamol, 52 placebo) |