Hypertonic Saline as Therapy for Pediatric Concussion

NCT ID: NCT01612494

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Normal Saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: OTHER

intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour

Hypertonic Saline

Group Type: EXPERIMENTAL

Hypertonic Saline

Intervention Type: DRUG

intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour

Interventions

Hypertonic Saline

intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour

Intervention Type: DRUG

Normal Saline

intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour

Intervention Type: OTHER

Other Intervention Names

3%; HTS; NS

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Angela Lumba, MD

Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela K Lumba, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Mary Hilfiker, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Rady Children's Hospital Emergency Department

San Diego, California, United States

Countries

United States

Other Identifiers

HTS-100423

Identifier Type: -

Identifier Source: org_study_id