Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Not Applicable

Recruiting

Conditions: Sleep Apnea Syndromes in Children
Tonsil Stone
Sleep-Disordered Breathing
Tonsillar Hypertrophy
Tonsil Disease
Sleep Apnea, Obstructive
Tonsillitis

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty	Lateral pharyngoplasty	Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty	Tonsillectomy	Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
Tonsillectomy +/- adenoidectomy	Tonsillectomy	Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.

Primary Outcome Measures

Name	Time	Method
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention	Change between baseline (immediately post-op) through 6 weeks after surgery	Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room
Level of post-operative pain	Change between baseline (immediately post-op) through 6 weeks after surgery	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.
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention	Change between baseline (immediately post-op) through 6 weeks after surgery	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

Secondary Outcome Measures

Name	Time	Method
Post-operative duration (in days) to normal oral intake	Change between baseline (immediately post-op) through 6 weeks after surgery	Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal

Locations (4): Loma Linda University Professional Building - Murrieta
🇺🇸
Murrieta, California, United States
Pediatric Ear, Nose, and Throat Surgery and Audiology
🇺🇸
San Bernardino, California, United States
SAC Health - ENT Clinic
🇺🇸
San Bernardino, California, United States
Loma Linda University ENT/Head & Neck Surgery
🇺🇸
Riverside, California, United States