Use of Salt-Water Solution to Improve Symptoms in Concussion
Completed · Not applicable · Has a placebo group
Conditions studied: Brain Concussion, Post-Concussion Symptoms
In brief
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.
Key facts
- Study ID
- NCT00142090
- Run by
- Rady Children's Hospital, San Diego
- People needed
- 8
- Starts
- 2004-11-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2009-02-03
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Children's Hospital San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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