Moller 2005a.
Methods | Randomized, double‐dummy, placebo and active‐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 Paracetamol group Entered/completing: 51/51 Age (mean, SD): 24.5 ± 2.9 Sex (male, %): 69 Propacetamol group Entered/completing: 51/51 Age (mean, SD): 24.3 ± 3.6 Sex (male, %): 57 Placebo group Entered/completing: 50/50 Age (mean, SD): 24.5 ± 2.8 Sex (male, %): 68 |
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Interventions | Intervention: IV paracetamol 1 g Control: propacetamol 2 g Placebo: 100 ml saline, or 100 ml solution (double‐dummy) |
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Outcomes | Primary outcome: pain relief (VRS) Maximum pain relief, time of maximum pain relief, time to onset of pain relief, TOTPAR Pain intensity (VRS, VAS) and derived summary measures Time to rescue medication (oral ibuprofen 400 mg) Global evaluation (categorical) |
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Source of funding | Supported by the Bristol‐Myers Squibb Company | |
Were treatment groups comparable at baseline? | Yes: demographics and baseline postoperative pain | |
Details of preoperative pain | Participants with other painful physical conditions were excluded | |
Notes | Propacetamol and paracetamol were compared to placebo and then propacetamol was compared to paracetamol | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Treatments were allocated according to block randomization (each block, n = 6) |
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 | Low risk | "Treatments were randomized among 152 patients. No patients withdrew from the study and all patients were evaluated for 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 (51 paracetamol, 51 propacetamol, 50 placebo) |