Phase 2
N=44
Hypertonic Saline as Therapy for Pediatric Concussion
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01612494 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Change in Pain — 1.14; 3.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hypertonic Saline (Drug); Normal Saline (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain |
1.14; 3.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01612494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.