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. 2016 Mar 31;2016(3):CD011008. doi: 10.1002/14651858.CD011008.pub2

Navigante 2010.

Methods Randomised parallel study
Participants Ambulatory participants with moderate to severe dyspnoea at rest
Mean age 55 years
31 participants in the morphine arm and 32 participants in the midazolam arm
Interventions Oral morphine: 3 mg then incremental steps at 30 minutes until 50% reduction in dyspnoea
Compared to oral midazolam: 2 mg up titrated 25% until 50% reduction in dyspnoea
Outcomes Dyspnea intensity
Adverse events
Notes Compared morphine to midazolam
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned (using a random number generator in 1:1 ratio in blocks of 6) to 1 of the 2 treatment groups. Numbered envelopes that were used to implement the randomisation were concealed until interventions were assigned.
Allocation concealment (selection bias) Low risk Participants were randomly assigned (using a random number generator in 1:1 ratio in blocks of 6) to 1 of the 2 treatment groups. Numbered envelopes that were used to implement the randomisation were concealed until interventions were assigned.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk This study was single blinded, that is only participants were blinded. However, adequacy was unclear – similarity of preparation – morphine group given laxatives.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk This study was single blinded, and only participants were blinded. The investigators were aware of the treatment allocation.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There was only 1 withdrawal in each group, which was unrelated to the intervention.
Selective reporting (reporting bias) Low risk The study authors appear to have reported all outcome data.
Other bias Low risk We judged that this trial appeared to be free of other sources of bias.
Size bias High risk There were 30 participants per treatment arm and the study was designed as a parallel trial; there were < 50 participants per treatment arm.