TranExamic Atomized for Pediatric post-Operative Tonsillectomy hemorrhage (TEAPOT): Study protocol for a pilot...

Area of Science:

• Pediatric Otolaryngology
• Surgical Hemorrhage Control
• Pharmacokinetics

Background:

• Tonsillectomy is a common pediatric surgery with a 5% complication rate of post-tonsillectomy hemorrhage (PTH).
• Current PTH management often involves returning to the operating room for cauterization.
• Nebulized tranexamic acid (TXA) shows promise in reducing PTH severity, but requires clinical validation.

Purpose of the Study:

• To evaluate the feasibility of a clinical trial for nebulized TXA in pediatric PTH.
• To assess the safety and pharmacokinetics of nebulized TXA in children with secondary PTH.
• To gather preliminary data for a definitive clinical trial on TXA for pediatric post-tonsillectomy hemorrhage.

Main Methods:

• The TranExamic Atomized for Pediatric post-Operative Tonsillectomy hemorrhage (TEAPOT) trial protocol was designed.
• Children with secondary PTH presenting to the ED will be randomized to receive nebulized TXA or placebo.
• Outcomes include feasibility, protocol adherence, OR return rates, pain, anxiety, TXA concentrations, biomarkers, and adverse events.

Main Results:

• This study is a protocol design and feasibility assessment, not reporting definitive treatment results.
• Preliminary data will inform the design of a larger, confirmatory clinical trial.
• The study will provide insights into the feasibility and pharmacokinetics of nebulized TXA in this pediatric population.

Conclusions:

• The TEAPOT trial protocol provides a framework for evaluating nebulized TXA in pediatric PTH.
• Feasibility and pharmacokinetic data are crucial for planning a definitive trial.
• This research aims to establish a less invasive treatment option for post-tonsillectomy bleeding.