NCT00142090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 3, 2009

Status Verified

January 1, 2009

Enrollment Period

1.1 years

First QC Date

September 1, 2005

Last Update Submit

February 2, 2009

Conditions

Brain ConcussionPost-Concussion Symptoms

Keywords

Brain ConcussionPost-Concussion SyndromeClosed Head InjuryTraumatic Brain InjuryHypertonic Saline Solution

Outcome Measures

Primary Outcomes (1)

  • Improvement in headache.

Secondary Outcomes (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).

Study Arms (2)

2

EXPERIMENTAL

3% Hypertonic saline

Drug: 3% Hypertonic saline

1

PLACEBO COMPARATOR

Normal saline

Drug: Placebo

Interventions

3% Hypertonic salineDRUG
2
PlaceboDRUG

Normal saline

1

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital San Diego

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Brain ConcussionPost-Concussion SyndromeHead Injuries, ClosedBrain Injuries, Traumatic

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Karim T Rafaat, MD

    Rady Children's Hospital, San Diego

    PRINCIPAL INVESTIGATOR

  • Bradley M Peterson, MD

    Rady Children's Hospital, San Diego

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

November 1, 2004

Primary Completion

December 1, 2005

Study Completion

July 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-01

Locations

US(1)