| Methods |
RCT comparing etomidate (n = 18) to fentanyl and midazolam combination (n = 12) |
| Participants |
Adult trauma patients requiring intubation < 48 hours post‐injury |
| Interventions |
Etomidate 0.3 mg/kg versus fentanyl 100 µg and midazolam 5 mg |
| Outcomes |
Primary: Adrenal function (ACTH Stimulation test and random serum cortisol levels at 4 to 6 h after intervention). Secondary: vasopressor requirements, post‐intubation haemodynamics, transfusion requirements, mortality, hospital LOS2, ICU LOS2, ventilator days |
| Notes |
Clarification about sequence generation, allocation concealment, and details about the protocol violations have been sought from the author. Raw data for ACTH stimulation tests were provided by the author. Risk of bias judgments may change once this information is received |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Reports "randomization packets" but no description of sequence generation. "Medical personnel who participated in randomization procedures were trained". Effects on randomization unclear |
| Allocation concealment (selection bias) |
Low risk |
"Envelopes were half [etomidate] and half [Fentanyul/Midazolam] and sealed. Opened in ED or helicopter or ICU by person intubating. No way it could have been predicted prior to enrolment. Envelopes were identical." (Hildreth 2013 [pers comm]) |
| Incomplete outcome data (attrition bias)
Mortality |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Incomplete outcome data (attrition bias)
Adrenal Gland Dysfunction |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Incomplete outcome data (attrition bias)
Hospital LOS |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Incomplete outcome data (attrition bias)
ICU LOS |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Incomplete outcome data (attrition bias)
Duration of mechanical Ventillation |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Incomplete outcome data (attrition bias)
Vasopressor requirements |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Incomplete outcome data (attrition bias)
Organ Dysfunction |
Low risk |
N/A |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
This study reported 61 eligible patients, but only enrolled 30. Of the 31 patients who were excluded, 14 (45%) were excluded for protocol violations. In an unblinded study, this raises significant concerns for the reviewers, and this study is judged at high risk of bias for attrition bias |
| Selective reporting (reporting bias) |
Low risk |
All relevant data reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Non‐blinded study. Unlikely to affect empiric outcomes relevant to this review, however, when considered in the context of the high rate of patient exclusion for protocol violation, the risk of bias due to unblinded assessors and personnel is high |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Non‐blinded study. Unlikely to affect empiric outcomes relevant to this review |
