Lim 2008.
Study characteristics | ||
Methods | Parallel RCT – 2 groups. | |
Participants | Women who spontaneously delivered a singleton fetus and sustained perineal damage requiring repair; women were randomised as soon as possible after completion of perineal suturing A state‐funded public maternity hospital which also serves as an affiliated teaching hospital in Penang, Malaysia Women with known allergy to NSAIDs, epidural during labour, 3rd‐ 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 | Dates of study: January to June 2006 Funding sources: NR Declarations of interest: NR |
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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 | Prespecified outcomes were all reported |
Other bias | Low risk | No significant differences between the groups in any characteristics |