Bing Chen1, Yun-sheng Liu. 1. Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha 410008, China.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of moderate dosage naloxone in acute moderate and severe traumatic brain injury. METHODS: A randomized double-blind prospective clinical trial was done to compare the differences of naloxone and saline in acute moderate and severe traumatic brain injury. Naloxone or saline placebo was intravenously given for 10 days. We followed up for at least 1 month. The indexes of assessment of prognosis were Glasgow outcome scale, verbal function and motor function. RESULTS:Forty cases were enrolled in the clinical trial, evenly divided into the naloxone group, and the saline group. On the 10th day after the treatment, Glasgow coma scale, improvement of abnormity of blood pressure, rhythm of the heart and breath in the naloxone group were significantly higher than those in the saline group. The mortalities of the naloxone group and the saline group were 0 and 5% respectively. After the one-month follow-up, Glasgow outcome scale and verbal function in the naloxone group were significantly higher than those in the saline group. In addition, a patient was found with mania possibly caused by naloxone. CONCLUSION: Early application of moderate dosage naloxone in acute traumatic brain injury may significantly reduce the mortality rate and improve the recovery of nerve function.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of moderate dosage naloxone in acute moderate and severe traumatic brain injury. METHODS: A randomized double-blind prospective clinical trial was done to compare the differences of naloxone and saline in acute moderate and severe traumatic brain injury. Naloxone or saline placebo was intravenously given for 10 days. We followed up for at least 1 month. The indexes of assessment of prognosis were Glasgow outcome scale, verbal function and motor function. RESULTS: Forty cases were enrolled in the clinical trial, evenly divided into the naloxone group, and the saline group. On the 10th day after the treatment, Glasgow coma scale, improvement of abnormity of blood pressure, rhythm of the heart and breath in the naloxone group were significantly higher than those in the saline group. The mortalities of the naloxone group and the saline group were 0 and 5% respectively. After the one-month follow-up, Glasgow outcome scale and verbal function in the naloxone group were significantly higher than those in the saline group. In addition, a patient was found with mania possibly caused by naloxone. CONCLUSION: Early application of moderate dosage naloxone in acute traumatic brain injury may significantly reduce the mortality rate and improve the recovery of nerve function.