Status:
COMPLETED
Use of Salt-Water Solution to Improve Symptoms in Concussion
Lead Sponsor:
Rady Children's Hospital, San Diego
Conditions:
Brain Concussion
Post-Concussion Symptoms
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
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 s...
Detailed Description
A concussion is formally described as a clinical syndrome characterized by immediate and transient changes in brain function including alteration of mental status and level of consciousness, resulting...
Eligibility Criteria
Inclusion
- Greater than or equal to 6 years of age
- Admitted for observation of closed head injury
- GCS greater than or equal to 13
- Presence of headache
- CT scan showing no brain injury or only a small contusion (an area of low attenuation less than 10 mm or a punctuate area of high attenuation with surrounding edema less than 5mm). CT evidence of high or mixed attenuation would be consistent with a hemorrhagic lesion and therefore not qualify to participate in the study. Evidence of skull fractures and cephalohematomas on CT would not exclude the patient from the study.
Exclusion
- Age less than 6
- GCS less than 13
- Radiographic evidence of extra-axial blood or subarachnoid blood
- Possible or witnessed posttraumatic seizure
- Developmental delay/ mental retardation
- Underlying cardiac or renal pathology
- Suspected and/or documented use of alcohol and/or illicit substances
- Medication history which includes administration of acetaminophen within 4 hours prior to enrollment or chronic anticoagulant use (ie: Coumadin, Aspirin
- Associated injuries requiring the use of narcotics for analgesia (ie: long bone injuries, deep laceration repair)
- Intubation
- Non-English speaking
- No parental consent
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00142090
Start Date
November 1 2004
End Date
July 1 2007
Last Update
February 3 2009
Active Locations (1)
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1
Children's Hospital San Diego
San Diego, California, United States, 92123