Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
This study is looking at whether adding a procedure called lateral pharyngoplasty to a tonsillectomy helps children. Lateral pharyngoplasty involves using sutures (stitches) to reshape the back of the throat. Researchers want to see if children who have both procedures experience less pain, eat and drink better, and have a lower risk of bleeding after surgery compared to those who only have a tonsillectomy. This study is for children aged 3 to 17 years old who are having a tonsillectomy at Loma Linda University Health. The goal is to understand if this combined approach leads to better outcomes for children with conditions like sleep apnea and tonsillitis. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional, randomized controlled trial planning to enroll 160 participants. Participants will be randomly assigned to receive either a tonsillectomy alone or a tonsillectomy with lateral pharyngoplasty.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for pain and bleeding from immediately after surgery through 6 weeks after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
At a glance
Conditions
Where it's being run
4 sites across 1 statesStudy leadership
- Tsungju O-Lee, MD · PRINCIPAL_INVESTIGATOR · Loma Linda University Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Level of post-operative painChange 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 interventionChange 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 interventionChange 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