TEAPOT Study Multisite

Number of patients enrolled per month

Assess target enrollment of patients per site per month.

Number of nebulizations per patient

Evaluate the ability to nebulize at least two doses of TXA to children with PTH

Indirect local concentration of nebulized TXA

Limited data on nebulized TXA systematic absorption. Topical PK studies of TXA document a significant reduction in systematic levels but the same hemostasis effect. Collection of two blood samples from each participant. This will verify a pulmonary physiological-based PK model (PBPK) (i.e., nasal cavity, pharynx, and lung) that indirectly predicts the oropharyngeal and systematic concentration of nebulized TXA.

Systemic Concentration of nebulized TXA

Pharmacokinetics samples will be collected after completion of the last nebulized treatment received within sixty minutes. A second time point should then be collected after sixty minutes up to eight hours from last nebulization, separated from the previous time point by at least sixty to ninety minutes. The serum TXA levels will be used to verify a TXA Physiological-based Pharmacokinetic model and determine the population variability. This PBPK model is built by our research pharmacist based on extensive research already completed on TXA distribution and metabolism. Once the model is built, the investigators only need a one to two samples to determine if the model accurately reflects collect samples. The investigators will develop a base model to determine a best-fit compartmental model, distribution, and elimination kinetics. The investigators will also use stochastic models to evaluate between-subject variability in PK parameters.

Number of return visits to the OR

The need for return to the Operating Room (OR) for surgical management of PTH) will be followed for up to seven days after randomization

Estimated blood loss

Determine the estimated blood loss per participant

Number of recurrences of PTH

Number of participants in which there was a recurrence of post-tonsillectomy hemorrhage after the study drug was administered

Number of blood transfusions required

Blood product transfusion volume will be measured at discharge or 24 hours (whichever comes first). This will include the volume of packed red blood cells, platelets, plasma, cryoprecipitate, or whole blood. Any mention of blood loss in electronic health records from emergency, anesthesiology, or surgeons' notes will be recorded.

Wong-Baker FACES Pain Rating Scale or FLACC (Face, Legs, Activity, Cry, Consolability) Score

Admission of this pain scale will be age dependent, but yields the same score for the patient selection of pain or the visual cues available for pain assessment by the study team. Wong-Baker FACES Pain scale: The participant rates their pain from 0=No hurt to 10=Hurts worst, with a higher score indicating greater pain. FLACC Score: Scores 5 items from 0-2 with a total possible score of 10. A higher score indicates more pain.

Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Adults

The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.

Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Children

The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.