RecruitingEarly Phase 1NCT06580509

TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study

TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Pilot and Feasibility Study


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

12 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Inclusion Criteria3

  • Received a tonsillectomy
  • Presents to the ED with secondary* post-tonsillectomy hemorrhage
  • Children between age of 2 to 17 years of age (i.e., before their 18th birthday) *Secondary post-tonsillectomy hemorrhage is defined as greater than 24 hours from their primary tonsillectomy operation (arrival in recovery/PACU).

Exclusion Criteria6

  • Known and documented bleeding or clotting disorder.
  • Known pregnancy.
  • Patients with known hypersensitivity or allergic response to tranexamic acid.
  • Parents or guardians who cannot communicate in English or Spanish.
  • Intubation prior to enrollment.
  • Previously enrolled patients.

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Interventions

DRUGTranexamic Acid Injectable Product

Participants will receive three doses of TXA 500 mg (5 mL of TXA 100mg/ml) nebulized using a PARI LC D Disposable Nebulizer or equivalent over 10-15 minutes using 8 or greater liter/minute of gas flow.

OTHERNormal Saline

Participants will receive three 5 ml doses of placebo (normal saline) nebulized using a PARI LC D Disposable Nebulizer or equivalent over 10-15 minutes using 8 or greater liter/minute of gas flow.


Locations(1)

University Hospital

San Antonio, Texas, United States

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NCT06580509


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