Phase 2 Completed N=44 Randomized Triple-blind Treatment

Hypertonic Saline as Therapy for Pediatric Concussion

Postoperative Pain

Source: ClinicalTrials.gov NCT01612494 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcomePrimary: Change in Pain — 1.14; 3.5 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain	1.14; 3.5	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.