Ward 1985.
| Methods | Randomised controlled trial. | |
| Participants | Consecutive patients with head injuries over the age of 12 years who had either an acute intradural haematoma or no mass lesion whose best motor response was abnormal flexion or extension.
Treatment started after head injury regardless of ICP. 53 people were included in this study; 27 in the barbiturate group and 26 in the control group. |
|
| Interventions | Pentobarbital: Loading dose 5‐10 mg/kg until burst‐suppression on EEG. Maintenance 1‐3 mg/kg with serum level monitoring. | |
| Outcomes | ICP and body temperature during the first four days of treatment, and morbidity and mortality one year following injury. | |
| Notes | The study took place between January 1979 and April 1983 in Virginia, USA. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...a randomised, controlled trial of prophylactic pentobarbital therapy..." p.383, abstract |
| Allocation concealment (selection bias) | Low risk | Quote: "...the cases were randomly drawn for placement into a control group and a barbiturate‐treated group." p.384 |
| Blinding (performance bias and detection bias) Participants | Low risk | Quote: "head‐injured patients over the age of 12 years who had either an acute intradural hematoma (subdural and/or intracerebral, large enough to warrant surgical decompression) or no mass lesion but whose best motor response was abnormal flexion or extension." p.384 Review authors' judgement: The patients were unaware of their treatment allocation |
| 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 | Complete outcome data were reported for all outcomes used in this review. |
| Selective reporting (reporting bias) | Unclear risk | Review authors' judgement: The study report mentions a study protocol. We were unable to obtain a copy of the study protocol in order to assess selective reporting. |
| Other bias | Unclear risk | None known. |
CPP: cerebral perfusion pressure GOS = Glasgow outcome score GCS = Glasgow coma score ICP= Intracranial pressure ICU = Intensive care unit EEG = Electroencephalograph TBI: traumatic brain injury