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

Mignault 1995.

Methods Design: randomised, double blind, two‐phase cross‐over 5‐day study. Prestudy titration period to establish total daily requirement
Duration: 2 x 5 days + titration period
Setting: not stated
Participants Moderate to severe cancer pain
N = 27 (19 included in analysis)
Mean age 57 years (range 38 ‐ 69)
Weight 65 (47 ‐ 104) kg
Interventions
  1. Mm/r 8‐hourly

  2. Mm/r 12‐hourly


Rescue medication: MIR
Outcomes PI: VAS x 4 daily
Adverse events: 4‐point categorical scale
Participant global rating: 4‐point scale
Participant preference: 4‐point scale
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 "blinding maintained by administration of active and placebo tablets each day"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "blinding maintained by administration of active and placebo tablets each day"
Incomplete adverse event outcome data‐ patient level Unclear risk Unable to determine
Selective reporting bias for adverse events Low risk Incidence of 9 different AEs
Size High risk < 50 participants per treatment arm