Sleep Apnea, Obstructive, Sleep Apnea Syndromes in Children, Sleep-Disordered Breathing, Tonsil Disease, Tonsillar Hypertrophy, Tonsillitis, Tonsil Stone
Conditions
Keywords
Tonsillectomy, Post-tonsillectomy hemorrhage, Post-tonsillectomy complication, Lateral pharyngoplasty
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.
Interventions
PROCEDURELateral pharyngoplasty
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.
PROCEDURETonsillectomy
Extracapsular tonsillectomy
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
At the beginning of the study, each surgeon will receive an 80-item numbered list for which a random generator has been used to assign lateral pharyngoplasty or no lateral pharyngoplasty to each study participant. Each participant recruited for the study will undergo the correlating procedure at the time of surgery. Thus, the surgeon is necessarily not blinded, but the participant and parents would be blinded, and informed consent for the procedure would be for tonsillectomy +/- adenoidectomy, possible lateral pharyngoplasty.
Intervention model description
Participants ages 3-17 years undergoing tonsillectomy for any reason will be randomized to either undergo tonsillectomy +/- adenoidectomy (standard of care practice) or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention). Parents of participants in both arms will be given post-operative worksheets to document pain scores, pain medication administration, estimates of daily per os intake, and any complications.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTShannon Calaguas, MD
CONTACTEthan Frank, MD
PRINCIPAL_INVESTIGATORTsungju O-Lee, MD
Loma Linda University Health
Outcome results
None listed