Finn 1993.
Methods | Design: Randomised, double blind (double dummy), two‐period cross‐over study Duration of study: 6 days (day 1: usual MIR; days 2 and 3 either Mm/r or MIR (with matched placebo); days 4 and 5 cross‐over) Setting: outpatients |
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Participants | Cancer pain requiring > 60 mg MIR/daily N = 37 (34 completed) Mean age 59 years |
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Interventions |
Dose adjustment allowed Non‐opioid medications continued Rescue medication: paracetamol, MIR or sub‐cut/IM morphine |
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Outcomes | PI: VAS x 3 daily, and 4‐point categorical (Karnofsky) Adverse events Use of rescue medication Participant preference |
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Notes | Oxford Quality Score: R = 2, DB = 2, W = 1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomisation by using randomisation schedule provided to the responsible pharmacist" |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "blinded drug supplies packaged daily by the responsible pharmacist" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "blinded drug supplies packaged daily by the responsible pharmacist" |
Incomplete adverse event outcome data‐ patient level | Low risk | > 90% of participants included |
Selective reporting bias for adverse events | High risk | Only selected AEs reported |
Size | High risk | < 50 participants per treatment group |