Could a simple mist replace surgery for Kids' Post-Tonsillectomy bleeding?
NCT ID NCT07565753
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests whether a medicated mist (nebulized tranexamic acid) can safely stop bleeding in children after tonsil removal. About 30 kids aged 2 to 17 who experience bleeding will receive the mist instead of going back to the operating room. The goal is to see if this approach can avoid repeat surgery and its risks, such as anesthesia complications and emotional distress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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: 1. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hasbro Childrens' Hospital
NOT_YET_RECRUITINGProvidence, Rhode Island, 02903, United States
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University Hospital
NOT_YET_RECRUITINGSan Antonio, Texas, 78229, United States
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University of California at Davis Medical Center
RECRUITINGDavis, California, 95819, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New surgical patch aims to stop bleeding faster in liver operations
- Drug may sharpen Surgeon's view during shoulder operations
- New patch aims to stop bleeding faster in keyhole surgery
- Could a simple drug cut blood loss in leg fracture surgery?
- Could a simple mist replace surgery for bleeding tonsils?