Brain Concussion Clinical Trial
Official title:
Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | July 2007 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Rady Children's Hospital, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in headache. | |||
Secondary | 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). |
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