Sleep Apnea, Obstructive Clinical Trial
Official title:
Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
NCT number | NCT05575401 |
Other study ID # | 5210282 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2023 |
Est. completion date | August 2024 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Professional Building - Murrieta | Murrieta | California |
United States | Loma Linda University ENT/Head & Neck Surgery | Riverside | California |
United States | Pediatric Ear, Nose, and Throat Surgery and Audiology | San Bernardino | California |
United States | SAC Health - ENT Clinic | San Bernardino | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Genc E, Hanci D, Ergin NT, Dal T. Can mucosal sealing reduce tonsillectomy pain? Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):725-30. doi: 10.1016/j.ijporl.2005.12.005. Epub 2006 Jan 18. — View Citation
Kim JS, Kim BG, Kim DH, Hwang SH. Efficacy of pillar suture for post-tonsillectomy morbidity in children: a meta-analysis. Braz J Otorhinolaryngol. 2021 Sep-Oct;87(5):583-590. doi: 10.1016/j.bjorl.2019.12.007. Epub 2020 Jan 25. — View Citation
Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91. — View Citation
Shu Y, Yao HB, Yang DZ, Wang B. Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. Arch Argent Pediatr. 2018 Oct 1;116(5):316-321. doi: 10.5546/aap.2018.eng.316. English, Spanish. — View Citation
Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Change between baseline (immediately post-op) through 6 weeks after surgery | |
Primary | 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. | Change between baseline (immediately post-op) through 6 weeks after surgery | |
Primary | Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention | Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room | Change between baseline (immediately post-op) through 6 weeks after surgery | |
Primary | 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 | Change between baseline (immediately post-op) through 6 weeks after surgery | |
Secondary | 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 | Change between baseline (immediately post-op) through 6 weeks after surgery |
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