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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Two figure-of-8 sutures using 3-0 vicryl are used to approximate the anterior and posterior tonsillar pillars and reconstruct the continuous mucosal covering of the lateral pharyngeal walls.
Extracapsular tonsillectomy
Loma Linda University Professional Building - Murrieta
Murrieta, California, United States
NOT_YET_RECRUITINGLoma Linda University ENT/Head & Neck Surgery
Riverside, California, United States
RECRUITINGPediatric Ear, Nose, and Throat Surgery and Audiology
San Bernardino, California, United States
NOT_YET_RECRUITINGSAC Health - ENT Clinic
San Bernardino, California, United States
NOT_YET_RECRUITINGLevel of post-operative pain
Will use the Wong-Baker FACES pain scale, which shows a series of faces ranging from a happy face at 0 (representing no pain) to a crying face at 10 (representing the worst pain imaginable). Parent/caregiver will document the pain score and pain medication administrations/duration of use.
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
Count of subject/caregiver reports or presentations to a healthcare facility due to a post-tonsillectomy hemorrhage event that does not require control of hemorrhage in the operating room
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Post-operative duration (in days) to normal oral intake
Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
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