Bohn 1989.
Methods | Randomised controlled trial. | |
Participants | Children (age 1‐18 years) with severe head injury (GCS ≤ 7). 82 people were included in the trial, 41 in each study group. |
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Interventions | High‐dose phenobarbitone (loading dose 50 mg/kg followed by 20 mg/kg/day) or no phenobarbitone. | |
Outcomes | Death and GOS were measured at the time of hospital discharge and at 6 months, ICP, sepsis. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Review authors' judgement: Experiencing a head injury occurs randomly. |
Allocation concealment (selection bias) | High risk | Correspondence with author in 1997. Quote: "Patients allocated to treatment group according to which ICU physician was on duty." |
Blinding (performance bias and detection bias) Participants | Low risk | Review authors' judgement: Low risk as people had a Glasgow Coma Scale score of 7 or less and therefore had reduced cognitive function. |
Blinding (performance bias and detection bias) Treating physicians | Unclear risk | Not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data on mortality and disability are reported in full. |
Selective reporting (reporting bias) | Unclear risk | Review authors' judgement: Not assessed as we were unable to obtain the study protocol. The authors report there was a study protocol. |
Other bias | Unclear risk | Review authors' judgement: None known. |