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

Hanks 1995.

Methods Design: randomised, double blind (double dummy), two phase cross‐over study. Assessments x 4 on last day of each treatment phase
Duration: 2 x 3 days
Setting:
Participants Advanced malignant disease with pain requiring at least 400 mg morphine/day
N = 25 (19 completed)
M 11, F 14
Mean age 56 years (range 35 ‐ 69)
Interventions
  1. Mm/r 100 mg

  2. Mm/r 200 mg


Exact dose made up with standard CR morphine tablets (30 ‐ 100 mg), but dose remained constant throughout study
Rescue medication: morphine elixir ≤ 1/6 total daily dose
Outcomes PI: VAS
Symptom score: categorical 4‐point. Scores taken x 4 on days 3 and 6
Use of rescue medication
Morphine plasma concentrations in 4 participants
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 "patients were 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 double dummy crossover ...." "identical tablets"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "double blind double dummy crossover ...." "identical tablets"
Incomplete adverse event outcome data‐ patient level Low risk > 90% of participants included
Selective reporting bias for adverse events High risk Selective reporting of AEs
Size High risk < 50 participants per treatment arm