Mizuguchi 1990.
Methods | Design: multicentre, randomised, single blind (double dummy), cross‐over study Duration: 2 x 3 days. No washout Setting: not clear, probably inpatient |
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Participants | Cancer pain N = 46 Mean age 58 years (±12) |
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Interventions |
Previoius medication continued |
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Outcomes | PI: 4‐point categorical scale PR: 6‐point categorical scale Sleep Adverse events Global assessment |
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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) | Unclear risk | "randomisation by code". 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 | Unclear risk | "matching placebos were prepared" but states single blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "matching placebos were prepared" |
Incomplete adverse event outcome data‐ patient level | Unclear risk | Unable to determine |
Selective reporting bias for adverse events | High risk | Selective reporting |
Size | High risk | < 50 participants per treatment arm |