Use of Salt-Water Solution to Improve Symptoms in Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142090
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : February 3, 2009
Information provided by:
Rady Children's Hospital, San Diego

Brief Summary:

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 or disease Intervention/treatment Phase
Brain Concussion Post-Concussion Symptoms Drug: 3% Hypertonic saline Drug: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of 3% Hypertonic Saline to Improve Clinical Symptoms in Concussed Patients
Study Start Date : November 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 2
3% Hypertonic saline
Drug: 3% Hypertonic saline
Placebo Comparator: 1
Normal saline
Drug: Placebo
Normal saline

Primary Outcome Measures :
  1. Improvement in headache.

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142090

United States, California
Children's Hospital San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
Principal Investigator: Karim T Rafaat, MD Rady Children's Hospital, San Diego
Study Director: Bradley M Peterson, MD Rady Children's Hospital, San Diego

Responsible Party: Division of Pediatric Critical Care, Rady Children's Hospital, San Diego Identifier: NCT00142090     History of Changes
Other Study ID Numbers: 04139-C
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: January 2009

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, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating