Akural 2009.
Methods | RCT, DB, single oral dose, 4 parallel groups. Medication administered when baseline pain was of at least moderate intensity. Pain assessed at baseline and every 15 min to 2 h, then hourly to 8 h. |
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Participants | Surgical removal of 1 or 2 impacted third molars. N = 82 (84 cases; 2 participants had 2 operations), 76 (78 cases) assessed (4 protocol violations, 2 inadequate pain). M 31, F 45. Mean age: 23 years. |
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Interventions | Ketoprofen 100 mg, n = 20. Paracetamol 1000 mg, n = 18. Ketoprofen 100 mg + paracetamol 1000 mg, n = 20. Placebo, n = 20. |
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Outcomes | PI: standard 4‐point scale. Use of rescue medication. Time to use of rescue medication. AEs: any, serious. Withdrawals. |
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Notes | Oxford Quality Score: R1, DB2, W1. Participants asked to wait ≥ 1 h before using rescue medication. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomly assigned", "computer‐generated allocation schedule". |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy design, "patients were given identical sealed containers of study medication". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐dummy design, "patients were given identical sealed containers of study medication". |
Size | High risk | < 50 participants per treatment arm. |