Nebulized tranexamic acid to stop post-tonsillectomy bleeding in children

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

We will try a medicated mist (nebulized tranexamic acid) to stop bleeding after tonsillectomy in children aged 2 to 17.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06580509 on ClinicalTrials.gov

What this trial studies

This pilot gives three consecutive doses of nebulized tranexamic acid (TXA) to children who present with secondary post-tonsillectomy bleeding. Doses are weight-based: 500 mg per dose for children over 25 kg and 250 mg per dose for children under 25 kg, delivered via a standard nebulizer over roughly one hour. Treatments are administered in a clinical setting (emergency department or hospital) by trained staff, and patients are monitored for bleeding control and safety. The trial will record whether the mist stops bleeding without needing return to the operating room or blood transfusion.

Who should consider this trial

Good fit: Children aged 2 to 17 who present to the ED with secondary post-tonsillectomy hemorrhage (more than 24 hours after the original operation) and who do not have contraindications to TXA are ideal candidates.

Not a fit: Patients with known bleeding or clotting disorders, pregnancy, a known allergy to tranexamic acid, those already intubated, or those who require immediate operative control of bleeding are unlikely to benefit from this nebulized approach.

Why it matters

Potential benefit: If successful, this approach could stop bleeding without another surgery or transfusion, avoiding additional anesthesia and hospital procedures for children.

How similar studies have performed: Topical and nebulized uses of tranexamic acid have shown promising results in small studies and case reports for upper airway bleeding, but robust pediatric trials for post-tonsillectomy nebulized TXA are limited.

Eligibility criteria

Inclusion Criteria:

1. Received a tonsillectomy
2. Presents to the ED with secondary\* post-tonsillectomy hemorrhage
3. 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 Criteria:

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

Where this trial is running

San Antonio, Texas

• University Hospital — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Andrew D Meyer, MD, MS — The University of Texas Health Science Center at San Antonio
• Study coordinator: Andrew D Meyer, MD, MS

Conditions: Hemorrhage, Surgical, Tonsillar Bleeding, Tranexamic Acid, Nebulizer, Post tonsillectomy hemorrhage