He 2017.
Methods | Parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 120 participants Number analysed: 120 participants Naloxone
Naloxone + pantoprazole
Inclusion criteria
Exclusion criteria: ‐ Baseline imbalances: no significant difference in primary disease, sex, age, and course of disease between study group and control group |
|
Interventions |
Naloxene
Naloxene + pantoprazole
Adherence to regimen: ‐ Duration of trial: May 2009 to May 2014 Duration of follow‐up: ‐ |
|
Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
|
|
Notes |
Setting: ICU Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: Signed informed consent was required by all participants Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: ‐ |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information to allow judgment |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to allow judgment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: insufficient information to allow judgment |
Blinding (detection bias) Clinically important upper GI bleeding | High risk | Comment: no details about criteria for diagnosis of upper GI bleeding or blinding of outcome assessors reported |
Blinding (detection bias) Nosocomial pneumonia | Unclear risk | Comment: Study did not address this outcome |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Unclear risk | Comment: insufficient information to allow judgement |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: insufficient information to allow judgement |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported in Methods section also reported in Results |
Other bias | Unclear risk | Comment: insufficient information to allow judgement |