Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: f
View:

• Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health

Locations
United States
California
Loma Linda University Professional Building - Murrieta
NOT_YET_RECRUITING
Murrieta
Loma Linda University ENT/Head & Neck Surgery
RECRUITING
Riverside
Pediatric Ear, Nose, and Throat Surgery and Audiology
NOT_YET_RECRUITING
San Bernardino
SAC Health - ENT Clinic
NOT_YET_RECRUITING
San Bernardino
Contact Information
Primary
Shannon Calaguas, MD
scalaguas@llu.edu
(909) 558-8558
Backup
Ethan Frank, MD
efrank@llu.edu
(909) 558-8558
Time Frame
Start Date: 2023-05-17
Estimated Completion Date: 2026-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Tonsillectomy +/- adenoidectomy
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.
Experimental: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
Sponsors
Leads: Loma Linda University

This content was sourced from clinicaltrials.gov