Hypertonic Saline as Therapy for Pediatric Concussion

University of California San Diego

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pain

Treatments: Drug: Hypertonic Saline; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01612494

HTS-100423

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Treatment:

Other: Normal Saline

Hypertonic Saline

Experimental group

Treatment:

Drug: Hypertonic Saline