Bashar 2013.
Methods | Double‐blind parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 146 participants Number analysed: 120 participants Ranitidine
Pantoprazole
Inclusion criteria
Exclusion criteria
Baseline imbalances: We found no statistically significant differences between the 2 groups regarding baseline characteristics, such as age, sex, or APACHE II |
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Interventions |
Ranitidine
Pantoprazole
Adherence to regimen: ‐ Duration of trial: July 2011 to July 2012 Duration of follow‐up: ‐ |
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Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought in review but not reported in trial
Outcomes reported, but not used in the review
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Notes |
Setting: ICU, Iran Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: Trial was approved by the Ethics Committee of Hamedan University of Medical Sciences. Informed consent: Written informed consent was obtained from legal guardians of participants Clinical trials registration: ‐ Sample size calculation: ‐ Conflicts of interest: ‐ |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patients were randomised using online random allocation software (www.allocationsoftware.com)" |
Allocation concealment (selection bias) | Unclear risk | Comment: not enough information reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patients and the attending intensivists responsible for data collection were blinded to the assigned groups" |
Blinding (detection bias) Clinically important upper GI bleeding | Unclear risk | Comment: Trial did not address this outcome |
Blinding (detection bias) Nosocomial pneumonia | Low risk | Quote: "Patients underwent chest radiography which was repeated at least twice a week" Comment: Objective outcome measurement unlikely to introduce bias |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Low risk | Quote: "The patients and intensivists responsible for data collection were blinded to the assigned groups" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: All participants were followed up until discharge |
Selective reporting (reporting bias) | Low risk | Comment: All outcomes listed in the Methods section were reported in the Results section |
Other bias | Low risk | Comment: no other sources of bias suspected |