Dreiser 1994.
Methods | R, DB, PC, parallel groups Patch applied twice daily Assessed at baseline, 3, 7 days |
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Participants | Traumatic ankle sprain (< 2 days) N = 131 M 84, F 47 Mean age 34 years Baseline pain ≥ 50 mm |
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Interventions | Flurbiprofen patch, 2 x 40 mg daily, n = 65 Placebo patch, n = 66 Rescue medication: paracetamol. Ice or light restraint allowed Exclusions: 1 from flurbiprofen group for protocol violation |
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Outcomes | PGE: 4‐point scale (responder = "good" or "very good") Improvement in pain: VAS (mean data) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
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 | Placebo patch was "non‐medicated (but otherwise identical)" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Size | High risk | < 50 participants per treatment arm |