Balzanelli 1996.
Methods | RCT, DB, 2 parallel groups, multiple dose study. Medication administered when baseline pain was of moderate to severe intensity, then every 8 h for total of 3 days. Pain assessed at 0, 30 min, and 1, 2, 3, 4, 5 ,6, 8 h, then daily. |
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Participants | Surgical removal of impacted third molars. N = 60. M 37, F 23. Mean age: approximately 37 years. |
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Interventions | Ketoprofen lysine 80 mg, n = 30. Placebo, n = 30. |
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Outcomes | PI: 0‐100‐mm VAS. PGE: standard 5‐point scale. AE: any, serious. Withdrawals. Tolerability 4‐point scale at end of study. |
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Notes | Oxford Quality Score: R1, DB2, W1. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported. |
Allocation concealment (selection bias) | Unclear risk | Method not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "placebo indistinguishable". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "placebo indistinguishable". |
Size | High risk | < 50 participants per treatment arm. |