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

Sponsor:	Rady Children's Hospital, San Diego
Information provided by:	Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:	NCT00142090

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Efficacy Study
Official Title:	Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients

Resource links provided by NLM:

MedlinePlus related topics: Concussion Dietary Sodium Drinking Water Headache 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
2: Experimental 3% Hypertonic saline	Drug: 3% Hypertonic saline
1: Placebo Comparator Normal saline	Drug: Placebo Normal saline

Show Detailed Description

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
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

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

No publications provided

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

Craniocerebral Trauma
Brain Concussion
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Head Injuries, Closed

Central Nervous System Diseases
Post-Concussion Syndrome
Wounds, Nonpenetrating
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on February 08, 2010