Rico 2000.
Methods | Design: randomised, double blind, two‐way cross‐over Duration: 2 x 7 days with 3‐day washout Setting: not stated |
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Participants | Oncologic pain N = 44 30 women, 14 men Mean age 55 years Baseline pain > 6/10 |
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Interventions | (1) codeine 120 mg daily to max 320 mg daily (average max dose 49 ± 15 mg x 4 daily) (2) tramadol 160 mg daily to max 400 mg daily (average max dose 68 ± 24 mg x 4 daily) All participants also received paracetamol 500 mg x 4 daily |
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Outcomes | PI: 10 cm VAS Patient preference Adverse events |
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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 | Method used to generate sequence not clearly stated |
Allocation concealment (selection bias) | Unclear risk | Method not clearly stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method not clearly stated, used the same number of drops and both had bitter taste |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method not clearly stated, used the same number of drops and both had bitter taste |
Incomplete adverse event outcome data‐ patient level | Unclear risk | Denominator not clear |
Selective reporting bias for adverse events | High risk | Selective reporting of a few AEs |
Size | High risk | < 50 participants per treatment arm |