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 |