Could a simple mist replace surgery for bleeding tonsils?
NCT ID NCT06580509
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
After a child has their tonsils removed, bleeding can sometimes occur and may require another surgery. This pilot study tests whether a nebulized mist of the drug tranexamic acid (TXA) can stop the bleeding without needing to touch the sore area. Twelve children aged 2 to 17 who experience post-tonsillectomy bleeding will receive either the TXA mist or a placebo. The main goal is to see if the treatment is feasible and to measure how much of the drug enters the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tranexamic acid (TXA) given as a nebulized mist
- What this could lead to
- If it works, this could offer a simple, non-surgical way to stop bleeding after tonsil removal in children, reducing the need for repeat surgery or blood transfusions.
- What could go wrong
- This is a very early pilot study with only 12 children, so it is too small to prove effectiveness. The treatment may not work as hoped, and there is a risk of side effects from the medication.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 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
1 site. 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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University Hospital
RECRUITINGSan Antonio, Texas, 78229, United States
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