Methods | RCT, DB, single oral dose, parallel groups. Assessed at t = 1/2, 1 hour and then hourly for 5 hrs. Medication taken when pain of moderate to severe intensity |
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Participants | Impacted third molar removal n = 148 Age: Adults |
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Interventions | DHC 30 mg, n = 49 Placebo, n = 50 |
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Outcomes | Measures: PI (9 point scale ) nonstandard PR (5 point scale) standard Analgesic outcome: DHC 30 mg was not significantly different to placebo. 5 hr TOTPAR: DHC 30 mg: 4.2 Placebo: 2.6 |
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Notes | Remedication allowed at t > 2 hrs. If remedicated patients were withdrawn and their PR set to zero for all further time points Withdrawals: 18 withdrew: 9 insufficient pain, 7 did not return assessment forms, 1 did not complete assessment forms, 1 postoperative complications Adverse effects: No serious adverse effects were reported and no patients withdrew as a result. DHC 30 mg: 1/49 with 1 AE Placebo: 1/50 with 3 AE Quality score: 3 |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Yes | A - Adequate |