Mignault 1995.
Methods | Design: randomised, double blind, two‐phase cross‐over 5‐day study. Prestudy titration period to establish total daily requirement Duration: 2 x 5 days + titration period Setting: not stated |
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Participants | Moderate to severe cancer pain N = 27 (19 included in analysis) Mean age 57 years (range 38 ‐ 69) Weight 65 (47 ‐ 104) kg |
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Interventions |
Rescue medication: MIR |
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Outcomes | PI: VAS x 4 daily Adverse events: 4‐point categorical scale Participant global rating: 4‐point scale Participant preference: 4‐point scale |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 1. Total = 4/5 | |
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 | Low risk | "blinding maintained by administration of active and placebo tablets each day" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "blinding maintained by administration of active and placebo tablets each day" |
Incomplete adverse event outcome data‐ patient level | Unclear risk | Unable to determine |
Selective reporting bias for adverse events | Low risk | Incidence of 9 different AEs |
Size | High risk | < 50 participants per treatment arm |