About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
Disqualifiers
Subjects with congenital syndromes and/or developmental delay
Subjects with cancer
Subjects with gastrostomy tube use or dependence
Subjects undergoing intracapsular tonsillectomy
Trial design
Parallel
Treatments tested in this trial
Lateral pharyngoplasty
Procedure/SurgeryTwo 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.
Tonsillectomy
Procedure/SurgeryExtracapsular tonsillectomy
Treatment groups
Trial outcomes
Primary outcomes
Level 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.
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room
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
Secondary outcomes
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
Other outcomes
Number of participants requiring intravenous fluid administration for dehydration
Presentation to healthcare facility due to lack of/perceived inadequate oral intake or decreased urination requiring intravenous fluid administration
Sponsors and contacts
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