Khalil 2006a.
Methods |
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Participants |
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Interventions | Treatment group
Control group
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Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised randomisation using a number generator |
Allocation concealment (selection bias) | Low risk | A third party placed the results of the randomisation in sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Envelopes were opened at close of the surgery and a third party prepared the study medication (placebo or treatment) which looked identical |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Initial power calculations resulted in an intended study population size of 60 patients. Following a global announcement of Pfizer that parecoxib was ‘contraindicated in patients with ischaemic heart disease’ further inclusion in the study was terminated at 40. Data of all 40 patients is presented |
Selective reporting (reporting bias) | Low risk | Study protocol matches outcomes presented |
Other bias | High risk | Commercial funding source Pharmacia, which is the manufacturer of Parecoxib |