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. 2016 Jul 14;2016(7):CD011352. doi: 10.1002/14651858.CD011352.pub2
Methods Parallel RCT – 2 groups.
Participants Women who spontaneously delivered a singleton fetus and sustained perineal damage requiring repair in a state‐funded public maternity hospital which also serves as an affiliated teaching hospital in Penang, Malaysia. Recruitment took place between January and June 2006; women were randomised as soon as possible after completion of perineal suturing.
Women with known allergy to NSAIDs, epidural during labour, third‐ or higher‐degree tear, instrumental vaginal birth, a history of peptic ulcer, asthma, thrombocytopenia, renal impairment or severe postpartum haemorrhage > 1500 mL, were excluded.
Interventions Intervention: celecoxib 200 mg (N = 163).
Comparison: diclofenac 100 mg (N = 165).
Outcomes
  • Pain scores on VAS of 0‐10.

  • Pain relief = overall relief satisfaction score on VAS of 0‐10 (N/A for review as results presented at 24 hours post‐treatment).

  • Adverse symptoms (on questionnaire – yes/no) ‐ (N/A for review as results presented at 24 hours post‐treatment).

  • Rescue medication (N/A for review as results presented at 24 hours post‐treatment).


Pain score (VAS) were completed by women at baseline and 1, 2, 4, 8, 12 and 24 hours. 4‐hour data used in the review.
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) Low risk Numbered sealed opaque envelopes.
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 Incomplete outcome data balanced across groups (attrition rates: 15 of 164 (9%) in the celecoxib groups and 15 of 165 (9%) in the diclofenac group). Analysis by intention‐to‐treat.
Selective reporting (reporting bias) Low risk Pre‐specified outcomes were all reported.
Other bias Low risk No significant differences between the groups in any characteristics.