Active — Not RecruitingNot Applicable

Hypertonic Saline for Mild TBI in Pediatric Patients

United States74 participantsStarted 2023-11-01

Plain-language summary

The purpose of this study is to compare two different treatments (normal saline and hypertonic saline) for concussions to see if one makes more of a difference in symptoms that can occur following concussions.

Who can participate

Age range8 Years – 17 Years

SexALL

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Inclusion criteria

✓. Age 8-17
✓. Blunt head injury within the past five days with any associated symptoms as outlined in the concussion inventory.
✓. English or Spanish speaking.
✓. Glasgow Coma Scale score of 13-15
✓. Treating provider plans to use saline administration as part of patient's treatment plan

Exclusion criteria

✕. Intracranial injury diagnosed by CT / MR Brain, though imaging is not a requirement for this study.
✕. Possible or witnessed posttraumatic seizure
✕. Developmental delay / intellectual disability
✕. Underlying cardiac, pulmonary, and renal pathology in which fluid administration or hypertonic saline may potentially be harmful, based on attending provider judgement.
✕. Suspected use of alcohol or illicit substances
✕. Associated injuries requiring the use of narcotics for analgesia

What they're measuring

Concussion symptoms severity

Timeframe: One month

Severity of concussion symptoms

Timeframe: One month

Trial details

NCT IDNCT07060105

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Head Injury, Minor trials