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

Babul 1998.

Methods Design: Randomised, double blind (double dummy), two‐period cross‐over study. Dose stabilisation using morphine; non‐morphine participants transferred to morphine
Duration: 2 x 7 days + dose stabilisation phase
Setting: not specified
Participants Cancer pain
N = 27 (22 completed and evaluated)
M 13, F 9
Mean age 55 years
Interventions
  1. Morphine CR oral tablet, 12‐hourly

  2. Morphine CR suppository, 12‐hourly


Dose ratio oral:rectal = 1:1
Non‐opioid analgesics continued
Rescue medication: MIR
Outcomes PI: VAS x 4 daily
PPI (6‐point categorised scale: no pain 0, mild pain 1, discomforting pain 2, distressing pain 3, horrible pain 4, excruciating pain 5)
Nausea, sedation: 100 mm VAS ‐ spontaneous + investigator‐reported
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 "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 Low risk "Double blind conditions maintained by use of matching placebos"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "Double blind conditions maintained by use of matching placebos"
Incomplete adverse event outcome data‐ patient level High risk AEs reported on fewer than 90% participants
Selective reporting bias for adverse events High risk 'AEs consistent with use of opioid analgesics in patients with advanced cancer'
Size High risk < 50 participants per treatment arm