Original article S24 Journal of Research in Medical Sciences | March 2012 Special Issue (1) | The effects of gabapentin on improvement of consciousness level in patients with traumatic brain injury: A randomized clinical trial Mohammad Reza Najafi 1 , Saeed Abrishamkar 2 , Seyed Ali Sonbolestan 3 , Hadid Hamrah 4 1 Associate professor, Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. 2 Professor, Department of Neurosurgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. 3 Student of Medicine, Isfahan Neuroscience Research Center And Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran. 4 Student of Medicine, School of Medicine And Student Research committee, Isfahan University of Medical Sciences, Isfahan, Iran. . BACKGROUND: Traumatic brain injury (TBI) is known as one of the most important causes of mortality in middle-aged population. The aim of this study was to evaluate the effects of gabapentin in improvement of consciousness level in these patients. METHODS: This randomized clinical trial was performed in March 2008 to September 2009. A total number of 60 patients from neurology clinics of Kashani Hospital (Isfahan, Iran) were randomly divided into two groups of 30 subjects as the case and control groups. The groups were respectively treated with 300 mg gabapentin and placebo twice a day for two weeks. The electroencephalogram (EEG), Glasgow Outcome Scale (GOS), and Glasgow Coma Scale (GCS) findings were evaluated in all patients before and one week after the intervention. RESULTS: The mean values of GCS and GOS before and after the treatment were not significantly different between the groups. This study showed significant changes in EEG patterns after treatment with gabapentin. CONCLUSIONS: Gabapentin might not be suggested for management of unconsciousness due to TBI. KEYWORDS: Gabapentin, Brain Injuries, Consciousness, Electroencephalography BACKGROUND Traumatic brain injury (TBI) is known as one of the most important causes of mortality in middle age population. It is assumed as the third cause of mortality through the whole course of life. Although different rates of mortality due to these injuries have been reported, an estimated rate of 2.5 per 1000 persons each year would be acceptable. Car accidents are the major causes of TBI. In fact, over 65% deaths in accidents are due to TBI. Therefore, good information about the mechanism and physiopathology of TBIs are needed for correct diagnosis and treatment. [1,2] Various medical regimens have been used to treat syndromes which happen after TBIs. In other words, there is no standard protocol of medical treatment some previous animal and human studies even suggested these treatments to possibly worsen the prognosis. [3] Different studies have evaluated the effects of some medications on complications of TBIs such as loss of consciousness, as a major problem. They reported some drugs like alpha‐2 agonists, antidepressants, antiepileptics, benzodiazepines, neuroleptics, opioids, and beta blockers to have some favorable effects. [4‐7] On the other hand, dysautonomia is one of the other TBI complications whose pharmacological management in comatose patients due to TBI is very important. Some studies have shown that gabapentin may be useful in these patients. [4] Gabapentin is a gamma aminobutyric acid (GABA) analogue whose exact mechanism of action is not known. [8] Among the several purposes that gabapentin is used for, treating seizures or pains is the most important. Some aspects of its mechanism of action is known especially in the field of pain controlling by having effects on GABA system through N‐type Ca2+ channels but other parts are still unclear. [9‐12] It may act by affecting the reticular activating system. Not enough studies have assessed the effects of this drug in improving consciousness level of TBI patients. Therefore, the aim of this study was to evaluate the effects of gabapentin on consciousness according to their Glasgow Coma Scale (GCS) and Glasgow Outcome Scale (GOS) scores and also electroencephalogram (EEG) results. METHODS Study population and design In this double blind, randomized clinical trial, patients were recruited from neurosurgery and emergency divisions of Kashani Hospital (Isfahan, Address of correspondence: Saeid Abrishamkar, Professor, Department of Neurosurgery, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Email: najafi@med.mui.ac.ir Received: 27-11-2011; Revised: 08-12-2011; Accepted: 07-12-2012 www.mui.ac.ir