Hypertonic Saline as Therapy for Pediatric Concussion
This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury.
The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline.
The null hypothesis was that there would be no difference in change of reported pain in either group.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department|
- Change in Pain [ Time Frame: Following therapy to 2-3 days post discharge ] [ Designated as safety issue: No ]Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.
- Change in Nausea and Vomiting [ Time Frame: from initial symptoms to 2-3 days post discharge ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Normal Saline||
Other: Normal Saline
intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
Other Name: NS
|Experimental: Hypertonic Saline||
Drug: Hypertonic Saline
intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612494
|United States, California|
|Rady Children's Hospital Emergency Department|
|San Diego, California, United States, 92123|
|Principal Investigator:||Angela K Lumba, MD||University of California, San Diego|
|Principal Investigator:||Mary Hilfiker, MD||University of California, San Diego|