Babul 1998.
Methods | Design: Randomised, double blind (double dummy), two‐period cross‐over study. Dose stabilisation using morphine; non‐morphine participants transferred to morphine Duration: 2 x 7 days + dose stabilisation phase Setting: not specified |
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Participants | Cancer pain N = 27 (22 completed and evaluated) M 13, F 9 Mean age 55 years |
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Interventions |
Dose ratio oral:rectal = 1:1 Non‐opioid analgesics continued Rescue medication: MIR |
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Outcomes | PI: VAS x 4 daily PPI (6‐point categorised scale: no pain 0, mild pain 1, discomforting pain 2, distressing pain 3, horrible pain 4, excruciating pain 5) Nausea, sedation: 100 mm VAS ‐ spontaneous + investigator‐reported |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised". 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 | Low risk | "Double blind conditions maintained by use of matching placebos" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Double blind conditions maintained by use of matching placebos" |
Incomplete adverse event outcome data‐ patient level | High risk | AEs reported on fewer than 90% participants |
Selective reporting bias for adverse events | High risk | 'AEs consistent with use of opioid analgesics in patients with advanced cancer' |
Size | High risk | < 50 participants per treatment arm |