Oztürk 2008.
Methods | Design: randomised, open label, parallel group study Duration: 15 days Setting: hospital and home |
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Participants | Lung cancer requiring WHO step 3 opioids for pain; 18 of fentanyl patients were treated in hospital, and 16 of morphine patients were treated in hospital, others were visited by doctors at home N = 50 M/F not reported Mean age 55 years (completers, range not stated) |
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Interventions |
Starting level: Participants requiring 200 to 400 mg tramadol used 25 μg/h TDF patches Participants requiring 500 to 600 mg oral tramadol used 50 μg/h TDF patches 120 mg slow release morphine Dose increased if inadequate response to maximum 100 mg/h TDF or 180 mg Mmr(41% and 23% changed, two participants in each group increased dose twice) Rescue medication: both groups given subcutaneous morphine if pain ‘unbearable’ (NRS > 3) |
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Outcomes | Pain: NRS (0‐10) Activities of daily living: Eastern Cooperative Oncology Group Adverse events |
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Notes | Oxford Quality Score: R = 1, DB = 0, W = 1. Total = 2/5 | |
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 | High risk | Open study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open study |
Incomplete adverse event outcome data‐ patient level | Low risk | >90% participants included |
Selective reporting bias for adverse events | High risk | Selective reporting |
Size | High risk | < 50 participants per treatment arm |