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Hypertonic Saline as a Therapy for Pediatric Concussive Pain: A Randomized Controlled Trial of Symptom Treatment in the Emergency Department

Lumba-Brown, Angela MD, FAAP*†‡; Harley, Jim MD, MPH†‡; Lucio, Simon MD; Vaida, Florin PhD§∥; Hilfiker, Mary PhD, MD, MMM#

doi: 10.1097/PEC.0000000000000084
Original Articles

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.

From the *Pediatric Emergency Medicine, Washington University School of Medicine, St Louis, MO; †PEMNetwork.org; ‡Division of Pediatric Emergency Medicine, Department of Emergency Medicine, University of California, San Diego, CA; §Division of Biostatistics and Bioinformatics, Department of Family and Preventive Medicine University of California, San Diego, CA; ∥Statistics Unit, HIV Neurobehavioral Research Program; and #Rady Children’s Hospital, University of California, San Diego, CA.

Disclosure: The authors declare no conflict of interest.

Reprints: Angela Lumba-Brown, MD, FAAP, Pediatric Emergency Medicine, Washington University School of Medicine, 660 S Euclid Ave, Campus Box 8116, St Louis, MO 63110 (e-mail: alumba@aol.com).

© 2014 Lippincott Williams & Wilkins, Inc.