Gabrail 2004.
Methods | Design: Randomised, double‐blind, two‐period cross‐over study. Prestudy open label stabilisation phase to establish fixed dosage that provided adequate analgesia for at least 2 consecutive days, required no more than 2 doses of rescue medication/day, and produced tolerable AEs ‐ used to calculate equianalgesic dose for study Duration: 2 x 7 ‐ 10 days + 3 ‐ 10‐day stabilisation phase Setting: outpatient |
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Participants | Moderate to severe pain secondary to cancer, requiring long‐term outpatient treatment with an opioid analgesic N = 44 (37 analysed for efficacy) M 21, F 23 Mean age 59 years (range 26 ‐ 81) |
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Interventions |
Dose adjustment allowed in first 3 days only Rescue medication: 15 mg oral morphine sulphate (IR) every 4‐6 hours as needed Other permitted medication not reported |
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Outcomes | PI: 11‐point NRS and BPI QoL: BPI (pain interference with 7 domains of quality of life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) Global assessment of treatment: participant and physician Adverse events Karnovsky performance status |
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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 | 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 | Study medication was "over encapsulated" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study medication was "over encapsulated" |
Incomplete adverse event outcome data‐ patient level | Low risk | > 90% of participants included |
Selective reporting bias for adverse events | Low risk | All treatment related AEs reported |
Size | High risk | < 50 participants per treatment arm |