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

Rodriguez 1994.

Methods Design: multicentre, randomised, double blind, parallel group study
Duration: 7 days
Setting: Oncology departments in Spain
Participants Cancer pain, with pre study intensity > 70/100 mm
N = 149 eligible, 121 participated
70% men
Mean age 61 years
Baseline VAS PI > 70/100
Interventions
  1. MIR 10 mg 4‐hourly, increasing to 30 mg 4‐hourly, n = 42

  2. Dipyrone 1 g 8‐hourly, increasing to 2 g 8‐hourly, + placebo to maintain blinding, n = 41

  3. Dipyrone 2 g 8‐hourly, + placebo to maintain blinding, n = 38


No other medication allowed
Rescue medication: paracetamol 300 mg and codeine 15 mg
Outcomes PI: VAS, daily
 Adverse events: check list ‐ severity judged by investigators
Notes Oxford Quality Score: R = 1, DB = 1, W = 1. Total = 3/5
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 Unclear risk "double blind". Method not described
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk "double blind". Method not described
Incomplete adverse event outcome data‐ patient level Low risk <90% participants included
Selective reporting bias for adverse events Unclear risk All AEs by events appear to be included
Size High risk < 50 participants per treatment arm