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Hypertonic Saline as Therapy for Pediatric Concussion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Angela Lumba, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01612494
First received: May 29, 2012
Last updated: June 3, 2012
Last verified: June 2012
History of Changes
  Purpose

This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury.

The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline.

The null hypothesis was that there would be no difference in change of reported pain in either group.


Condition Intervention Phase
Pain
 Drug: Hypertonic Saline
Other: Normal Saline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Change in Pain [ Time Frame: Within 20min prior to therapy and then one week thereafter with total outcome assessment not to exceed 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in nausea and vomiting [ Time Frame: Within 20min prior to therapy and then one week thereafter with total outcome assessment not to exceed 1 week ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline Other: Normal Saline
intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
Other Name: NS
Experimental: Hypertonic Saline Drug: Hypertonic Saline
intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour
Other Names:
  • 3%
  • HTS

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 4-17 years old
  • consent obtained
  • pain as a symptom of concussion
  • head CT negative for intracranial pathology

Exclusion Criteria:

  • younger than 4 years or older than 17 years
  • multi trauma
  • cardiac, neuro, renal history of disease
  • seizure
  • narcotic, drug use
  • pregnancy
  • head CT with traumatic intracranial pathology
  • no consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612494

Locations
United States, California
Rady Children's Hospital Emergency Department
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Angela K Lumba, MD University of California, San Diego
Principal Investigator: Mary Hilfiker, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Angela Lumba, MD, Fellow, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01612494     History of Changes
Other Study ID Numbers: HTS-100423
Study First Received: May 29, 2012
Last Updated: June 3, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013