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

Todd 2002.

Methods Design: multicenter, randomised, open label, two‐phase cross‐over study of two dosing regimens of MIR
Duration: 2 x 2 days, no washout
Setting: inpatients
Participants Cancer‐related pain adequately treated with MIR, stable for ≥ 2 days, with ≤ 2 doses of rescue medication
N = 24 (20 completed)
Median age 62 years (range 40 ‐ 89)
M 10, F 14
Interventions
  1. Regular dose of MIR at bedtime followed by regular dose at 4 h and 8 h later

  2. Double dose of MIR at bedtime followed by regular dose 8 h later


Rescue medication: MIR
Outcomes Use of rescue medication during night
PI for overnight and morning pain: NRS (0 ‐ 10)
Adverse events: 4‐point VRS
Notes Oxford Quality Score: R = 1, DB = 0, W = 1. Total = 2/5
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated randomised list
Allocation concealment (selection bias) Unclear risk Method not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open study
Incomplete adverse event outcome data‐ patient level Unclear risk Reported events not patients
Selective reporting bias for adverse events High risk Selective AEs reported
Size High risk < 50 participants per treatment arm