- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612494
Hypertonic Saline as Therapy for Pediatric Concussion
Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Rady Children's Hospital Emergency Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Normal Saline
|
intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
Other Names:
|
Experimental: Hypertonic Saline
|
intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain
Time Frame: Following therapy to 2-3 days post discharge
|
Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale.
There are 6 faces with 5 intervals.
Faces are numbered 0 to 10. Maximum score is the 6th face/10.
Minimum score is the first face/0.
Increasing faces represent increase in pain, decreasing faces represent decrease in pain.
No subscales were included.
|
Following therapy to 2-3 days post discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Angela K Lumba, MD, University of California, San Diego
- Principal Investigator: Mary Hilfiker, MD, University of California, San Diego
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HTS-100423
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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