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Hypertonic Saline as Therapy for Pediatric Concussion

NCT01612494 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-04-16

Study results available
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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

Interventions

DRUG

Hypertonic Saline

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

OTHER

Normal Saline

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

Sponsors & Collaborators

Principal Investigators

  • Angela K Lumba, MD · University of California, San Diego

  • Mary Hilfiker, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612494 on ClinicalTrials.gov