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 |
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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 |
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Outcomes | Dyspnea intensity Adverse events |
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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. |