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Use of Salt-Water Solution to Improve Symptoms in Concussion

This study has been completed.
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:
NCT00142090
First received: September 1, 2005
Last updated: February 2, 2009
Last verified: January 2009
History of Changes
  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:

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
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: 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 June 17, 2013