Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
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.
Conditions:
🦠 Sleep-Disordered Breathing 🦠 Sleep Apnea Syndromes in Children 🦠 Sleep Apnea, Obstructive 🦠 Tonsillitis 🦠 Tonsillar Hypertrophy 🦠 Tonsil Stone 🦠 Tonsil Disease
🗓️ Study Start (Actual) 17 May 2023
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) August 2024
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Murrieta, California, United States
📍 Riverside, California, United States
📍 San Bernardino, California, United States
📍 San Bernardino, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 3 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 October 2022
  • First Submitted that Met QC Criteria 7 October 2022
  • First Posted 12 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024