Use of Salt-Water Solution to Improve Symptoms in Concussion
Brain Concussion, Post-Concussion Symptoms
About this trial
This is an interventional treatment trial for Brain Concussion focused on measuring Brain Concussion, Post-Concussion Syndrome, Closed Head Injury, Traumatic Brain Injury, Hypertonic Saline Solution
Eligibility 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
Sites / Locations
- Children's Hospital San Diego
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
2
1
3% Hypertonic saline
Normal saline