Rodriguez 1994.
Methods | Design: multicentre, randomised, double blind, parallel group study Duration: 7 days Setting: Oncology departments in Spain |
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Participants | Cancer pain, with pre study intensity > 70/100 mm N = 149 eligible, 121 participated 70% men Mean age 61 years Baseline VAS PI > 70/100 |
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Interventions |
No other medication allowed Rescue medication: paracetamol 300 mg and codeine 15 mg |
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Outcomes | PI: VAS, daily Adverse events: check list ‐ severity judged by investigators | |
Notes | Oxford Quality Score: R = 1, DB = 1, W = 1. Total = 3/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised". Method used to generate sequence not clearly stated |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "double blind". Method not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "double blind". Method not described |
Incomplete adverse event outcome data‐ patient level | Low risk | <90% participants included |
Selective reporting bias for adverse events | Unclear risk | All AEs by events appear to be included |
Size | High risk | < 50 participants per treatment arm |