Moller 2005b.
| Methods | Randomized, double‐blinded, triple‐dummy, active‐ and placebo‐controlled Medication administered when baseline pain reached moderate‐to‐severe intensity within 4 h after surgery |
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| Participants | Type of surgery: third molar extraction Propacetamol group Entered/completing: 50/50 Age (mean, SD): 24.2 (range 18 to 39) Sex (male, %): 46 Placebo group Entered/completing: 25/25 Age (mean, SD): 23.4 (range 20 to 29) Sex (male, %): 44 |
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| Interventions | Intervention: 2 g propacetamol 15 min infusion Intervention: 2 g propacetamol 2 min bolus (not included in our analysis) Control: oral acetaminophen (not included in our analysis) Placebo: triple‐dummy, exact details not described |
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| Outcomes | Primary: time to analgesia onset (double‐click stopwatch method) Pain relief (categorical) and derived summary scores Pain intensity (VAS) and derived summary scores Global evaluation (categorical) Duration of analgesia (time when 50% of participants in a group requested rescue medication, oral ibuprofen 600 mg) |
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| Source of funding | The study was supported by a grant from Bristol–Myers Squibb | |
| Were treatment groups comparable at baseline? | Yes: sex, weight, baseline pain intensity. Age appears to be similar between the 2 groups included in our analysis. | |
| Details of preoperative pain | Not reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer‐generated randomization schedule assigned treatments to sequential patients |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding (performance bias and detection bias) All outcomes | Low risk | A triple‐dummy technique was employed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Treatments were randomized between 175 patients. No patients withdrew from the study and all 175 patients were evaluated by the intent‐to‐treat analyses and for 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 (50 propacetamol, 25 placebo) |