Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorLoma Linda University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lateral pharyngoplasty

    Procedure/Surgery

    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.

  • Tonsillectomy

    Procedure/Surgery

    Extracapsular tonsillectomy

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Tonsillectomy +/- adenoidectomyActive comparator 1 intervention
Group B: Tonsillectomy +/- adenoidectomy with lateral pharyngoplastyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Change between baseline (immediately post-op) through 6 weeks after surgery
2

Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention

Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room

Time frame
Change between baseline (immediately post-op) through 6 weeks after surgery
3

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

Time frame
Change between baseline (immediately post-op) through 6 weeks after surgery

Secondary outcomes

1

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

Time frame
Change between baseline (immediately post-op) through 6 weeks after surgery

Other outcomes

1

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

Time frame
Change between baseline (immediately post-op) through 6 weeks after surgery

Sponsors and contacts

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