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. 2014 May 29;2014(5):CD011056. doi: 10.1002/14651858.CD011056.pub2

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
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)
Interventions
  1. Oxycodone CR 12‐hourly (8 am and 8 pm)

  2. Oxymorphone 12‐hourly (8 am and 8 pm)


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
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
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