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.
Received a tonsillectomy
Presents to the ED with secondary* post-tonsillectomy hemorrhage
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).
Known and documented bleeding or clotting disorder.
Known pregnancy.
Patients with known hypersensitivity or allergic response to tranexamic acid.
Parents or guardians who cannot communicate in English or Spanish.
Parallel
Tranexamic Acid Injectable Product
DrugParticipants 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 interventionParticipants 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.
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
The participant rates their pain from 0=No hurt to 10=Hurts worst
State-Trait Anxiety Inventory (STAI) for Adults
A widely used self-reported anxiety assessment instrument with versions for children over eight years of age, adolescents, and adults is the State-Trait Anxiety Inventory (STAI). The assessment is composed of two separate scales used in assessing situational (STAI-State) and baseline (STAI-Trait) anxiety levels. For more information please see https://www.mindgarden.com/145-state-trait-anxiety-inventory-for-adults. Scale Range: Each part (State and Trait) of the STAI consists of 20 items, with scores ranging from 20 to 80. State Anxiety: Reflects how the respondent feels at a particular moment (e.g., calm, tense). Trait Anxiety: Measures how the respondent generally feels over time (e.g., relaxed, nervous). Score Interpretation: Higher Scores: Indicate higher levels of anxiety. A score above 40 is generally considered to suggest significant anxiety symptoms. Lower Scores: Indicate lower levels of anxiety.
State-Trait Anxiety Inventory for Children (STAIC)
Scale Range: Similar to the adult version, the STAIC has separate scales for state and trait anxiety, each with 20 items. Scores range from 20 to 60 for each scale. State Anxiety: Measures how children feel at the moment. Trait Anxiety: Assesses how children usually feel over time. Score Interpretation: Higher Scores: Reflect higher levels of anxiety. A score above 30 on either scale may indicate elevated anxiety. Lower Scores: Suggest lower levels of anxiety. Interpretation: High State Anxiety Scores: Indicate a current feeling of anxiety or stress, possibly due to a specific situation or event. High Trait Anxiety Scores: Suggest a predisposition to experiencing anxiety more frequently or intensely over time. Low Scores (Both State and Trait): Indicate calmness and a lower likelihood of anxiety, whether temporarily or as a general tendency.
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