S V Pillai1, V R Kolluri, A Mohanty, B A Chandramouli. 1. Department of Neurosurgery, National Institute of Mental Health and Neurosciences, Bangalore - 560029, India. svp@bgl.vsnl.net.in
Abstract
AIMS: The aim of this study was to establish whether nimodipine given orally soon after severe diffuse head injury for a period of three weeks improved outcome. MATERIAL AND METHODS: The present report analyzes the results of a prospective randomized double-blind placebo-controlled trial of nimodipine in 97 severe head injury patients (GCS Score < or =8) treated at the Department of Neurosurgery, NIMHANS, between January 1995 and June 1996. The patients were randomly assigned to two groups which were matched for age, sex, mode of injury, time interval from injury to admission, neurological status and CT scan findings. One group was given nimodipine 30 mg Q6H and the other group was given a placebo. The outcome of these patients at 6 months was evaluated using the Glasgow Outcome Score by and a psychologist. RESULTS: Results showed no significant difference in the functional and psychological outcome between the two groups, even in patients with subarachnoid hemorrhage. No adverse drug events were recorded. CONCLUSION:Oral nimodipine given for three weeks does not improve outcome in patients with severe diffuse head injury.
RCT Entities:
AIMS: The aim of this study was to establish whether nimodipine given orally soon after severe diffuse head injury for a period of three weeks improved outcome. MATERIAL AND METHODS: The present report analyzes the results of a prospective randomized double-blind placebo-controlled trial of nimodipine in 97 severe head injurypatients (GCS Score < or =8) treated at the Department of Neurosurgery, NIMHANS, between January 1995 and June 1996. The patients were randomly assigned to two groups which were matched for age, sex, mode of injury, time interval from injury to admission, neurological status and CT scan findings. One group was given nimodipine 30 mg Q6H and the other group was given a placebo. The outcome of these patients at 6 months was evaluated using the Glasgow Outcome Score by and a psychologist. RESULTS: Results showed no significant difference in the functional and psychological outcome between the two groups, even in patients with subarachnoid hemorrhage. No adverse drug events were recorded. CONCLUSION: Oral nimodipine given for three weeks does not improve outcome in patients with severe diffuse head injury.