Hypertonic Saline as Therapy for Pediatric Concussion

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rady Children's Hospital Emergency Department

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline

Drug

intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour

Other names: 3%, HTS

Normal Saline

Other

intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour

Other names: NS

Primary outcomes

Change in Pain

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Hypertonic Saline as Therapy for Pediatric Concussion: A Randomized Controlled Trial in the Emergency Department

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jun 5, 2012
Registry last updated: Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed