Methods | Multi‐arm RCT (2 studies reported in 1 publication; study E2). | |
Participants | Women with severe pain only, who gave consent, no complicating illness, were not breastfeeding and were expected to tolerate medication well at a maternity hospital, Caracus, Venezuela. | |
Interventions |
E2 study: fenoprofen 12.5 mg (N = 24); fenoprofen 25 mg (N = 23); fenoprofen 50 mg (N = 23); fenoprofen 100 mg (N = 23) and fenoprofen 200 mg (N = 23). Comparison: placebo in both E1 study (N = 27) and E2 study (N = 23). |
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Outcomes |
Data were obtained at baseline, and 1, 2, 3, 4 and 5 hours after taking the medication. 5‐hour data used in this review (included at 6‐hour time‐frame). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement on method used. |
Allocation concealment (selection bias) | Unclear risk | No clear statement. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No clear statement. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data on withdrawals due to need for rescue medication at < 2 hours not provided (or referred to in results section). |
Selective reporting (reporting bias) | High risk | Need for rescue medication not reported. |
Other bias | Low risk | None apparent; ‘no significant differences between treatment groups’. |