De Conno 1995.
Methods | Design: randomised, double blind (double dummy), two‐period cross‐over study. Assessments at 10, 20, 30, 40, 60, 90, 120, 180 and 240 mins daily Duration: 2 x 2 days Setting: outpatients |
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Participants | Advanced or metastatic cancer with PI > 30/100 mm at baseline, opioid‐naive
N = 34 M 23, F 11 Mean age 59 (SD 8.8; range 38 to 70) |
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Interventions |
Single dose administered on each of two days then crossover to other treatment. Use of NSAIDs allowed for first day |
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Outcomes | PI: VAS Nausea and sedation: VAS Number of vomiting episodes Time to pain relief |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 0. Total = 3/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly allocated ... according to a predetermined allocation sequence". 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 double dummy technique" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "double blind double dummy technique" |
Incomplete adverse event outcome data‐ patient level | Low risk | >90% participants included |
Selective reporting bias for adverse events | High risk | Only nausea, vomiting & sedation reported |
Size | High risk | < 50 participants per treatment arm |