Use of Salt-Water Solution to Improve Symptoms in Concussion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00142090|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : February 3, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion Post-Concussion Symptoms||Drug: 3% Hypertonic saline Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||July 2007|
3% Hypertonic saline
|Drug: 3% Hypertonic saline|
Placebo Comparator: 1
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142090
|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|