Ventafridda 1986.
Methods | Design: randomised, open label, parallel group study. Initial dose based on pain level and previous treatment, then titrated to adequate control Duration: 14 days Setting: home |
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Participants | Cancer pain, severe, uncontrolled N = 66 randomised, 54 included M 31, F 23 Mean age 55 years |
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Interventions |
All participants received diclofenac 150 mg daily and haloperidol 20 mg/day by injection |
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Outcomes | PI: 5‐point categorical scale (Integrated pain score) Adverse events |
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Notes | Oxford Quality Score: R = 1, DB = 0, W = 0. Total = 1/5 | |
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 | High risk | "not blinded" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "not blinded" |
Incomplete adverse event outcome data‐ patient level | Unclear risk | No denominator for data |
Selective reporting bias for adverse events | Unclear risk | Presented data for days with AEs |
Size | High risk | < 50 participants per treatment arm |