Flöter 1997.
Methods | Design: randomised, open label, parallel group study. Initial 7 ‐ 14 day titration with Kapanol or Mm/r Duration: 14 days + titration phase Setting: in‐ and outpatient |
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Participants | Mixed pain: 27/91 Kapenol and 26/74 MST had cancer pain N = 165 M 98, F 67 Mean age 55 years Weight 69 kg |
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Interventions |
Paracetamol, NSAIDs, antidepressants allowed; advised not to alter. Other opioids not permitted Rescue medication: MIR 10 mg |
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Outcomes | PI: VAS (physician assessment of pain control)
Quality of sleep
Rescue medication
Well being etc (patient diary) Adverse events |
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Notes | Oxford Quality Score: R = 2, DB = 0, W = 1. Total = 3/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomisation performed using a random number generator" |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open |
Incomplete adverse event outcome data‐ patient level | Low risk | > 90% of participants included |
Selective reporting bias for adverse events | Unclear risk | No details of specific AEs |
Size | Unclear risk | 50 ‐ 200 participants per treatment arm |