Use of Salt-Water Solution to Improve Symptoms in Concussion

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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).

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	September 2, 2005
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