Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Status Recruiting

Clinical Trial Summary

The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are: - Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? - Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? - Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.

Clinical Trial Description

This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05575401
Study type	Interventional
Source	Loma Linda University
Contact	Shannon Calaguas, MD
Phone	(909) 558-8558
Email	scalaguas@llu.edu
Status	Recruiting
Phase	N/A
Start date	May 17, 2023
Completion date	May 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.