Use of Salt-Water Solution to Improve Symptoms in Concussion
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ClinicalTrials.gov Identifier: NCT00142090 |
Recruitment Status
:
Completed
First Posted
: September 2, 2005
Last Update Posted
: February 3, 2009
|
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- No Results Posted
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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 |

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 |
Arm | Intervention/treatment |
---|---|
Experimental: 2
3% Hypertonic saline
|
Drug: 3% Hypertonic saline |
Placebo Comparator: 1
Normal saline
|
Drug: Placebo
Normal saline
|
- Improvement in headache.
- 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

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 ClinicalTrials.gov identifier (NCT number): NCT00142090
United States, California | |
Children's Hospital San Diego | |
San Diego, California, United States, 92123 |
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 |
ClinicalTrials.gov Identifier: | NCT00142090 History of Changes |
Other Study ID Numbers: |
04139-C 11266 |
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 |