| Methods |
Randomised controlled trial; not reported as double‐blind. |
| Participants |
Severe head injury (GCS 8 or less). |
| Interventions |
Compared two regimens of guiding the administration of mannitol, one according to neurological signs and physiological measurements, and the other using ICP monitoring. The protocol for the first group used neurological signs, GCS, ventilatory values and arterial blood gas to guide administration. In the second group, a 250ml bolus of mannitol (20%) was given if ICP >25mmHg, and subsequent boluses were given incrementally. |
| Outcomes |
Deaths and neurological disability were reported. Follow‐up was one year. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information provided in published study. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The patients were randomly assigned to one of two groups by means of sealed envelopes containing cards designating the assigned protocol: Group I (mannitol therapy based on ICP monitoring) or Group II (empirical mannitol therapy)". |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No information provided in published study. |
