Hypertonic Saline as Therapy for Pediatric Concussion
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pain
Started Mar 2010
Longer than P75 for phase_1 pain
1 active site
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
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedResults Posted
Study results publicly available
March 21, 2014
CompletedApril 16, 2019
April 1, 2019
2.1 years
May 29, 2012
June 17, 2013
April 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain
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
Study Arms (2)
Normal Saline
PLACEBO COMPARATORHypertonic Saline
EXPERIMENTALInterventions
intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour
intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
Eligibility Criteria
You may qualify if:
- years old
- consent obtained
- pain as a symptom of concussion
- head CT negative for intracranial pathology
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rady Children's Hospital Emergency Department
San Diego, California, 92123, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Angela Lumba-Brown
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Angela K Lumba, MD
University of California, San Diego
- PRINCIPAL INVESTIGATOR
Mary Hilfiker, MD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow
Study Record Dates
First Submitted
May 29, 2012
First Posted
June 5, 2012
Study Start
March 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 16, 2019
Results First Posted
March 21, 2014
Record last verified: 2019-04