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

Conditions

• Hemorrhage, Surgical
• Tonsillar Bleeding

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Tranexamic Acid Injectable Product — DRUG
  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.
• Normal Saline — OTHER
  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.

Study Details

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.

Key Dates

Start date

Feb 18, 2026

Status verified

Apr 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nebulized Tranexamic Acid
  Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
• Placebo Comparator: Nebulized Saline
  Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Primary Outcome Measure

Number of patients enrolled per month [ Time Frame: Baseline to 18 months (or duration of study) ]

Central Contacts

• Andrew D Meyer, MD, MS
  210-567-4424
  [email protected]
• Stephanie Perez, MHA
  (210) 450-8973
  [email protected]

Locations (1)

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