Hypertonic Saline as Therapy for Pediatric Concussion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612494
• Other study ID #: HTS-100423
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Hypertonic Saline
intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour

Other:
• Normal Saline
intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour

Locations

Country	Name	City	State
United States	Rady Children's Hospital Emergency Department	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	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.	Following therapy to 2-3 days post discharge