Use of Salt-Water Solution to Improve Symptoms in Concussion - Full Text View

Purpose

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.

Condition	Intervention
Brain Concussion Post-Concussion Symptoms	Drug: 3% Hypertonic saline Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients

Resource links provided by NLM:

MedlinePlus related topics: Concussion Nausea and Vomiting Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by Rady Children's Hospital, San Diego:

Primary Outcome Measures:

Improvement in headache.

Secondary Outcome Measures:

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).


Enrollment:	8
Study Start Date:	November 2004
Study Completion Date:	July 2007
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2 3% Hypertonic saline	Drug: 3% Hypertonic saline
Placebo Comparator: 1 Normal saline	Drug: Placebo Normal saline

Show Detailed Description

Eligibility


Ages Eligible for Study:	6 Years to 17 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142090

Locations


United States, California
Children's Hospital San Diego
San Diego, California, United States, 92123

Sponsors and Collaborators

Rady Children's Hospital, San Diego

Investigators


Principal Investigator:	Karim T Rafaat, MD	Rady Children's Hospital, San Diego
Study Director:	Bradley M Peterson, MD	Rady Children's Hospital, San Diego

More Information


Responsible Party:	Division of Pediatric Critical Care, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:	NCT00142090 History of Changes
Other Study ID Numbers:	04139-C 11266
Study First Received:	September 1, 2005
Last Updated:	February 2, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Rady Children's Hospital, San Diego:


Brain Concussion Post-Concussion Syndrome Closed Head Injury Traumatic Brain Injury Hypertonic Saline Solution

Additional relevant MeSH terms:


Brain Concussion Post-Concussion Syndrome Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases	Craniocerebral Trauma Trauma, Nervous System Head Injuries, Closed Wounds and Injuries Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 23, 2016