Todd 2002.
Methods | Design: multicenter, randomised, open label, two‐phase cross‐over study of two dosing regimens of MIR Duration: 2 x 2 days, no washout Setting: inpatients |
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Participants | Cancer‐related pain adequately treated with MIR, stable for ≥ 2 days, with ≤ 2 doses of rescue medication N = 24 (20 completed) Median age 62 years (range 40 ‐ 89) M 10, F 14 |
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Interventions |
Rescue medication: MIR |
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Outcomes | Use of rescue medication during night PI for overnight and morning pain: NRS (0 ‐ 10) Adverse events: 4‐point VRS |
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Notes | Oxford Quality Score: R = 1, DB = 0, W = 1. Total = 2/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated randomised list |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open study |
Incomplete adverse event outcome data‐ patient level | Unclear risk | Reported events not patients |
Selective reporting bias for adverse events | High risk | Selective AEs reported |
Size | High risk | < 50 participants per treatment arm |