Hypertonic Saline as Therapy for Pediatric Concussion

Phase 1

Completed

• Conditions: Pain
• Interventions: Other: Normal Saline; Drug: Hypertonic Saline

• Registration Number: NCT01612494
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-06-03
• Study First Posted: 2012-06-05
• Results First Submitted: 2013-06-17
• Results First Submitted QC: 2014-02-20
• Results First Posted: 2014-03-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	-
Hypertonic Saline	Hypertonic Saline	-

Primary Outcome Measures

Name	Time	Method
Change in Pain	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.

Trial Locations

Locations (1)

Rady Children's Hospital Emergency Department; 🇺🇸 San Diego, California, United States