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

De Conno 1995.

Methods Design: randomised, double blind (double dummy), two‐period cross‐over study. Assessments at 10, 20, 30, 40, 60, 90, 120, 180 and 240 mins daily
Duration: 2 x 2 days
Setting: outpatients
Participants Advanced or metastatic cancer with PI > 30/100 mm at baseline, opioid‐naive
 N = 34
M 23, F 11
Mean age 59 (SD 8.8; range 38 to 70)
Interventions
  1. Oral morphine 10 mg

  2. Rectal morphine 10 mg


Single dose administered on each of two days then crossover to other treatment. Use of NSAIDs allowed for first day
Outcomes PI: VAS
Nausea and sedation: VAS
Number of vomiting episodes
Time to pain relief
Notes Oxford Quality Score: R = 1, DB = 2, W = 0. Total = 3/5
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomly allocated ... according to a predetermined allocation sequence". 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 technique"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "double blind double dummy technique"
Incomplete adverse event outcome data‐ patient level Low risk >90% participants included
Selective reporting bias for adverse events High risk Only nausea, vomiting & sedation reported
Size High risk < 50 participants per treatment arm