CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Hypertonic Saline +1 moredrug
Likely dose
Hypertonic Saline 10mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01612494
NCT01612494Phase 2Completed
CompareCT.gov

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

University of California, San Diego·interventional·Posted Jun 5, 2012·Updated Apr 16, 2019

In Brief

A Phase 2 clinical trial evaluating Hypertonic Saline and Normal Saline for Pain. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2012
Enrollment StartMar 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.1 years ago

Interventions

Hypertonic Salinedrug

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

Normal Salineother

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