Investigating the effect of buprenorphine on pain in the acute phase of patients with mild traumatic brain injury: a double-blind clinical trial

INTRODUCTION: TBI is one of the main causes of neurological, behavioral, and physiological disorders. The aim of this pilot research was to assess the efficacy and safety of using buprenorphine in treatment of mild TBI complications. METHODS: This double-blind, randomized clinical trial included 36 mild TBI patients aged 18-65 years with mild TBI. Patients received either Buprenorphine (8 mg oral tablet) (18 cases), alongside standard TBI care (18 cases). Main outcome were pain intensity using the Visual Analogue Scale (VAS), cognition using the Working Memory Questionnaire, Glasgow Outcome Scale-Extended and Glasgow Coma Scale at baseline, which was used for the inclusion criteria to define severity of TBI (GCS score of 10-15 being mild TBI). We follow up patients at baseline and 14 days after intervention. RESULTS: There was a significant decrease in VAS scores among Buprenorphine group compared to the placebo group (p = 0.027). Both groups showed improvement in their GOSE and WMQ scores without significant differences between groups. There were no adverse effects associated with Buprenorphine use, including constipation, itching, depression, or headaches. CONCLUSION: Buprenorphine is an effective drug in the relief of pain among men with mild TBI. Nevertheless, the lack of generalization to women due to the exclusive selection of men, who make up most trauma patients (motorcyclists), and the fact that the research is done as a pilot study with a short follow-up period of two weeks, no neuropsychological tests conducted, and only one domain used to test cognitive function prevents us from drawing any conclusions on this matter.