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. |
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Interventions | Intervention: celecoxib 200 mg (N = 163). Comparison: diclofenac 100 mg (N = 165). |
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Outcomes |
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. |
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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) | 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. |