TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Pilot and Feasibility Study
The University of Texas Health Science Center at San Antonio
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.
Description
The study intervention involves administering nebulized tranexamic acid (TXA) to pediatric patients with traumatic hemorrhage (PTH). The intervention consists of three consecutive doses of nebulized TXA. The dosage of nebulized TXA is adjusted based on the child's weight. For children weighing more than 25 kg, each dose is 500 mg. For children weighing less than 25 kg, each dose is 250 mg. Frequency: The three doses of nebulized TXA are administered consecutively over the course of approximately an hour. Administration Method: Nebulized TXA is delivered through a nebulizer device. A nebulize…
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
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.…
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.
Location
- University HospitalSan Antonio, Texas