ORIGINAL ARTICLE
Hypertonic Saline as a Therapy for Pediatric Concussive Pain A Randomized Controlled Trial of Symptom Treatment in the Emergency Department Angela Lumba-Brown, MD, FAAP,*Þþ Jim Harley, MD, MPH,Þþ Simon Lucio, MD,þ Florin Vaida, PhD,§|| and Mary Hilfiker, PhD, MD, MMML
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 antiinflammatory 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 G 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. Key Words: concussion, pediatric mild traumatic brain injury, hypertonic saline, pediatric head injury, mild traumatic brain injury, pediatric concussion, concussion therapy, concussion treatment, closed-head injury, mTBI, TBI, HTS (Pediatr Emer Care 2014;30: 139Y145) 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 LRady 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
Hypertonic Saline as a Therapy for Pediatric Concussive Pain A Randomized Controlled Trial of Symptom Treatment in the Emergency Department Angela Lumba-Brown, MD, FAAP,*Þþ Jim Harley, MD, MPH,Þþ Simon Lucio, MD,þ Florin Vaida, PhD,§|| and Mary Hilfiker, PhD, MD, MMML
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 antiinflammatory 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 G 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. Key Words: concussion, pediatric mild traumatic brain injury, hypertonic saline, pediatric head injury, mild traumatic brain injury, pediatric concussion, concussion therapy, concussion treatment, closed-head injury, mTBI, TBI, HTS (Pediatr Emer Care 2014;30: 139Y145) 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 LRady 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
