TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study
Purpose
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.
Conditions
- Hemorrhage, Surgical
- Tonsillar Bleeding
Eligibility
- Eligible Ages
- Between 2 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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. Intubation prior to enrollment. 6. Previously enrolled patients.
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Two arm randomized, double-blind, controlled clinical trial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- To maintain blinding, all personnel except the investigational pharmacist and/or statistician will be unaware of the administered drug. The randomization schedule will be pre-determined by a central randomization process and prepared as "use next boxes" to streamline the process at enrollment
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
Detailed 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 nebulizer converts the liquid medication into a fine mist or aerosol, which is then inhaled by the patient. This method allows the medication to be delivered directly to the respiratory tract, where it can exert its effect on the bleeding site. Delivery Setting: The intervention may take place in a clinical setting, such as a hospital or outpatient clinic, where nebulizer devices and medical supervision are readily available. Each patient receives three nebulized independent doses of TXA in succession. The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications.