Bhettay 1978.
Methods |
Allocation: randomised Blinding: double‐blind Controlled: placebo Centre: multicentre Arm: 2 arms, cross‐over design |
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Participants |
Inclusion criteria: children with juvenile chronic arthritis Exclusion criteria: known history of contraindications to study drugs; receiving gold, d‐penicillamine, or corticosteroids; in a state of remission Baseline characteristics N = 30 Age: mean not reported, range 2 to 16 years Gender: male (unstated); female (unstated) Number randomised: intervention (15); control (15) Number completed: intervention (15); control (15) Setting and location: South Africa |
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Interventions |
Intervention group (N = 15): indomethacin (2 weeks), cross‐over ketoprofen (2 weeks) Control group (N = 15): ketoprofen (2 weeks), cross‐over indomethacin (2 weeks) Participants < 20 kg: ketoprofen 25 mg capsule twice daily; participants > 20 kg: ketoprofen capsules x 2 = 50 mg twice daily Participants < 20 kg: indomethacin 25 mg capsule twice daily; participants > 20 kg: indomethacin capsules x 2 = 50 mg twice daily Study duration: 5 weeks |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | Sources of funding: Maybaker (SA) (Pty) Ltd provided drug supplies. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Randomised drug administration, not participants |
Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Insufficient information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: Insufficient information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: All participants were accounted for. Lost to follow‐up and withdrawals explained. |
Selective reporting (reporting bias) | Unclear risk | Comment: Means and standard deviations not reported, nor blood sedimentation rate, haemoglobin level, platelet and white cell count. |
Size | High risk | Comment: Total participants = 30 (< 50 per treatment arm) |
Other bias | Low risk | Comment: No other potential sources of bias found. |