Deschamps 1992.
Methods | Design: randomised, double blind (double dummy), two‐period cross‐over study with titration phase Duration 2 x 7 days, no washout Setting: outpatients |
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Participants | Metastatic cancer with pain requiring opioids N = 20 Mean age 57 years (range 40 to 72) |
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Interventions |
No dose adjustment allowed after titration MIR (solution) for breakthrough; no other opioids/analgesics allowed |
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Outcomes | PI: 100 mm VAS Adverse events: verbal (6‐point) severity scale 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 | "randomised by Pharmaceutical company...using randomisation table" |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "titration and trial phases conducted under double blind conditions with double dummy technique" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "titration and trial phases conducted under double blind conditions with double dummy technique" |
Incomplete adverse event outcome data‐ patient level | High risk | AEs reported on fewer than 90% participants |
Selective reporting bias for adverse events | High risk | Common AEs only reported as mean scores |
Size | High risk | < 50 participants per treatment arm |