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. 2021 Jan 11;2021(1):CD011352. doi: 10.1002/14651858.CD011352.pub3

Behotas 1992.

Study characteristics
Methods Multi‐arm RCT ‐ 3 groups
Participants Women whose post‐episiotomy pain warranted analgesia
Hospital ‘Sainte‐Antonie’, Paris
Participants were followed up on day‐1 postpartum
Women with hepatic or renal malfunction, a previous duodenal ulcer and those whose condition contra‐indicated treatment with NSAIDs, were excluded
Interventions Intervention: ibuprofen 400 mg (N = 31)
Comparison: paracetamol 1 g (N = 28) and placebo (N = 31)
Outcomes
  • Pain intensity measured by VAS before, 30 minutes and thereafter hourly up to 6 hours (0 = no pain to 100 = worst possible pain); verbal scale at hour 0, hour 1 and hour 6 (0 = no pain to 5 = worst possible pain)

  • Degree of improvement in response to treatment (0 = no improvement to 4 = greatly improved).


4‐ and 6‐hourly pain data were only available for ibuprofen and not for the comparator treatments
Need for additional analgesia data (6 hours) were the only outcome data available for inclusion in the review
Notes Dates of study: NR
Funding sources: NR
Declarations of interest: NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated.
Allocation concealment (selection bias) Unclear risk Identical white containers only – insufficient information as to whether these were sequentially‐numbered and sealed
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 Low risk Data provided for all 90 participants (0% attrition rate in all groups)
Selective reporting (reporting bias) Low risk Prespecified outcomes were all reported
Other bias Low risk Participants were similar in terms of geographical background, socio‐professional status and their overall clinical picture