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

Deschamps 1992.

Methods Design: randomised, double blind (double dummy), two‐period cross‐over study with titration phase
Duration 2 x 7 days, no washout
Setting: outpatients
Participants Metastatic cancer with pain requiring opioids
N = 20
Mean age 57 years (range 40 to 72)
Interventions
  1. Mm/r 30, 60, 100 mg, given 12‐hourly (8 am and 8 pm)

  2. MIR 1 mg/ml and 5 mg/ml, given 4‐hourly with double dose at night


No dose adjustment allowed after titration
MIR (solution) for breakthrough; no other opioids/analgesics allowed
Outcomes PI: 100 mm VAS
Adverse events: verbal (6‐point) severity scale
Participant preference
Notes Oxford Quality Score: R = 2, DB = 2, W = 1. Total = 5/5
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomised by Pharmaceutical company...using randomisation table"
Allocation concealment (selection bias) Unclear risk Method not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "titration and trial phases conducted under double blind conditions with double dummy technique"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "titration and trial phases conducted under double blind conditions with double dummy technique"
Incomplete adverse event outcome data‐ patient level High risk AEs reported on fewer than 90% participants
Selective reporting bias for adverse events High risk Common AEs only reported as mean scores
Size High risk < 50 participants per treatment arm