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New surgical trick aims to slash kids' tonsillectomy pain

NCT ID NCT05575401

Symptom relief Sponsor: Loma Linda University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a quick stitching step (lateral pharyngoplasty) to standard tonsillectomy helps children recover better. About 160 kids aged 3-17 will be randomly assigned to get tonsillectomy with or without the extra stitch. Parents will track pain, eating, and any bleeding afterward. The goal is to see if the added procedure reduces pain, improves how soon kids can eat normally, and lowers the risk of serious bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lateral pharyngoplasty (a surgical procedure that stitches the throat walls to reduce pain and bleeding)
What this could lead to
If it works, this could lead to a simple surgical addition that makes tonsillectomy recovery less painful and safer for children.
What could go wrong
This is a relatively small, early-stage trial (160 children) at one hospital, so results may not apply to all kids. The added procedure could also carry its own risks, like infection or scarring.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

3 to 17 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health Exclusion Criteria: * Subjects with congenital syndromes and/or developmental delay * Subjects with cancer * Subjects with gastrostomy tube use or dependence * Subjects undergoing intracapsular tonsillectomy

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Conditions

The condition(s) this trial relates to.

adenoid hypertrophy obstructive sleep apnea syndrome sleep apnea syndrome tonsillitis tonsillolith

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep apnea syndromes in children Sleep apnea, obstructive Sleep disordered breathing Tonsil disease Tonsil stone Tonsillar hypertrophy Tonsillitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Loma Linda University ENT/Head & Neck Surgery

    RECRUITING

    Riverside, California, 92506, United States

  • Loma Linda University Professional Building - Murrieta

    NOT_YET_RECRUITING

    Murrieta, California, 92563, United States

  • Pediatric Ear, Nose, and Throat Surgery and Audiology

    NOT_YET_RECRUITING

    San Bernardino, California, 92408, United States

  • SAC Health - ENT Clinic

    NOT_YET_RECRUITING

    San Bernardino, California, 92410, United States

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