Overview
Use of Salt-Water Solution to Improve Symptoms in Concussion
Status:
Completed
Completed
Trial end date:
2007-07-01
2007-07-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Rady Children's Hospital, San Diego
Criteria
Inclusion Criteria:- 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 Criteria:
- 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