McGurk 1998.
Methods | RCT, DB, single oral dose, 5 parallel groups. Medication administered when baseline pain was of moderate to severe intensity. Pain assessed at 0, 10, 20, 30, 45, 60, 90 min, and 2, 3, 4, 5, 6 h. |
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Participants | Surgical removal of impacted third molars. N = 210 (200 in efficacy analysis). M 88, F 122. Mean age: 28 years. |
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Interventions | Dexketoprofen trometamol 12.5 mg, n = 44. Dexketoprofen trometamol 25 mg, n = 41. Dexketoprofen trometamol 50 mg, n = 43. Ketoprofen 50 mg (racemic), n = 43. Placebo, n = 39. |
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Outcomes | PI: 100‐mm VAS and standard 4‐point scale. PR: standard 5‐point scale. PGE: non‐standard 4‐point scale. Number using rescue medication. AEs: any, serious. Withdrawals. |
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Notes | Oxford Quality Score: R2, DB2, W1. 12‐h analgesic and anti‐inflammatory washout before surgery. Rescue medication permitted after 1 h. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomization list generated by a computer program in blocks of five patients". |
Allocation concealment (selection bias) | Unclear risk | Method not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "tablets of identical appearance to ensure double‐blind conditions". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "tablets of identical appearance to ensure double‐blind conditions". |
Size | High risk | < 50 participants per treatment arm. |