Hypertonic Saline for Mild TBI in Pediatric Patients

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Emergency Department Patient; Pediatric; Head Injury, Minor

Treatments: Other: Hypertonic Saline ( 3% Sodium Chloride Saline); Other: Normal Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT07060105

00004358

Details and patient eligibility

About

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.

Full description

This randomized, double-blinded prospective study aims to determine the utility and efficacy of 3% hypertonic saline (HTS) to combat acute and long-term sequelae of TBI. We plan to enroll 74 participants, ages 8-17, who present to the pediatric Emergency Department with a mild TBI. The intervention group (n=37) will receive 5ml/kg of 3% hypertonic saline, and the control group (n=37) will receive 5ml/kg of 0.9% normal saline. There is a maximum volume of 500ml for both fluids. A standardized concussion inventory score will be used to assess the severity of symptoms pre-infusion, and post-infusion. Participants (or their parent/guardian) will be asked to complete two additional inventory scores one week and one month after the injury, of which they will be reimbursed for successful completion. Primary outcomes will be the efficacy of HTS in treating acute and chronic concussion symptomatology, and secondary outcomes will include unscheduled revisits to the ED.

Enrollment: 74 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Hypertonic Saline

Experimental group

Description:

The intervention group (n=37) will receive 5ml/kg of 3% hypertonic saline

Treatment:

Other: Hypertonic Saline ( 3% Sodium Chloride Saline)

Normal Saline

Active Comparator group

Description:

Control group (n=37) will receive 5ml/kg of 0.9% normal saline

Treatment:

Other: Normal Saline (0.9% NaCl)