Use of Salt-Water Solution to Improve Symptoms in Concussion
The purpose of this study is to find out if 3% hypertonic saline (salt-water solution) given in a vein improves the headache that may be caused by a concussion. 3% hypertonic saline may also improve some of the other symptoms that may be caused by concussion (for example: confusion, nausea, vomiting).
This research is being done because there have been previous experience which suggests that 3% hypertonic saline has been beneficial in the treatment of children with more severe brain injury.
Drug: 3% Hypertonic saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients|
- Improvement in headache.
- Improvement in other clinical symptoms of concussion (decrease level of GCS, nausea, vomiting, inability to recall events, repetitive questioning, and disorientation to person, place, and time).
|Study Start Date:||November 2004|
|Study Completion Date:||July 2007|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
3% Hypertonic saline
|Drug: 3% Hypertonic saline|
Placebo Comparator: 1
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|United States, California|
|Children's Hospital San Diego|
|San Diego, California, United States, 92123|
|Principal Investigator:||Karim T Rafaat, MD||Rady Children's Hospital, San Diego|
|Study Director:||Bradley M Peterson, MD||Rady Children's Hospital, San Diego|