ABSTRACT
OBJECTIVE: Three-percent hypertonic saline (HTS) is a hyperosmotic therapy used in pediatric traumatic brain injury to treat increased intracranial pressure and cerebral edema. It also promotes plasma volume expansion and cerebral perfusion pressure, immunomodulation, and anti-inflammatory response. We hypothesized that HTS will improve concussive symptoms of mild traumatic brain injury. METHODS: The study was a prospective, double-blind, randomized controlled trial. Children, 4 to 7 years of age with a Glasgow Coma Scale score greater than 13, were enrolled from a pediatric emergency department following closed-head injury upon meeting Acute Concussion Evaluation criteria with head pain. Patients were randomized to receive 10 mL/kg of HTS or normal saline (NS) over 1 hour. Self-reported pain values were obtained using the Wong-Baker FACES Pain Rating Scale initially, immediately following fluids, and at 2 to 3 days of discharge. The primary outcome measure was change in self-reported pain following fluid administration. Secondary outcome measures were a change in pain and postconcussive symptoms within 2 to 3 days of fluid administration. We used an intention-to-treat analysis. RESULTS: Forty-four patients, ranging from 7 to 16 years of age with comparable characteristics, were enrolled in the study; 23 patients (52%) received HTS, and 21 (48%) received NS. There was a significant difference (P < 0.001) identified in the self-reported improvement of pain following fluid administration between the HTS group (mean improvement = 3.5) and the NS group (mean improvement = 1.1). There was a significant difference (P = 0.01) identified in the self-reported improvement of pain at 2 to 3 days after treatment between the HTS group (mean improvement = 4.6) and the NS group (mean improvement = 3.0). We were unable to determine a difference in other postconcussive symptoms following discharge. CONCLUSIONS: Three-percent HTS is more effective than NS in acutely reducing concussion pain in children.