title: Hypertonic saline as a therapy for pediatric concussive pain: a randomized controlled trial of symptom treatment in the emergency department.
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.
authors.affiliation: 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.
authors.forename: Angela
authors.initials: A
authors.lastname: Lumba-Brown
authors.forename: Jim
authors.initials: J
authors.lastname: Harley
authors.forename: Simon
authors.initials: S
authors.lastname: Lucio
authors.forename: Florin
authors.initials: F
authors.lastname: Vaida
authors.forename: Mary
authors.initials: M
authors.lastname: Hilfiker
mesh_terms: D001924:Brain Concussion / Q000150:complications* / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D004638:Emergency Treatment; D005260:Female; D006801:Humans; D008297:Male; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D010147:Pain Measurement; D010372:Pediatrics; D011446:Prospective Studies; D012462:Saline Solution, Hypertonic / Q000627:therapeutic use*
chemical_list: D012462:Saline Solution, Hypertonic