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. 2016 Jul 14;2016(7):CD011352. doi: 10.1002/14651858.CD011352.pub2
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).
Outcomes
  • Pain relief (0 = none, 1 = 25%, 2 = 50%, 3 = 75%, 4 = 100%).

  • Pain intensity (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain).

  • Additional (rescue) medication.


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).
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’.