Clinical trial NCT04910919: Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery
Official title: Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tonsillectomy
Keywords: honey
pediatrics
post-operative
pain
nausea
tonsillectomy
complimentary and alternative medicine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tonsillectomy is one of the most common surgeries performed in the United States, with over half a million performed annually in children younger than 15 years of age. Postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. Management of postoperative pain is often challenging and results in additional medical costs due to unplanned emergency room visits. Opioids such as codeine are commonly prescribed for pain control, however in 2013 the Food \& Drug Administration issued a black box warning for the use of codeine in post-tonsillectomy pediatric patients. The American Academy of Otolaryngology-Head and Neck Surgery recommends the use of acetaminophen and ibuprofen to successfully manage postoperative pain. With an extended recovery period, often longer than 7 days, alternative measures to reduce postoperative pain are needed. Honey has been proven to possess antibacterial and anti-inflammatory properties. This intervention will evaluate the effect of Tylenol, ibuprofen with honey on children's postoperative pain and nausea following tonsillectomy surgery.

Detailed description: This is a randomized intervention study where 100 pediatric tonsillectomy patients will received standard of care treatment for post-operative pain and randomized by their physician's standing orders on whether or not they include honey for pain management plus the standard of care alternating acetaminophen or Motrin dose (50 patients in the control group and 50 patients in the intervention group).

Patients/ families will be consented for the study during their clinic appointment, by the provider and/ or Registered Nurse (RN) after surgical intervention has been determined as the plan of care or day of surgery if the consent is not present on the EMR by the provider and/ or Holding Room RNs. They will be given a pain catastrophizing scale questionnaire to complete. Patient/ family will be instructed in the use of the medication, pain scale and nausea scale diary by the Holding Room RNs and again with the PACU RNs as they enter they first values before discharge to home. Patients admitted to an inpatient unit are excluded from the study.

The family will be called on post-op Day 1 and Day 4 to answer any questions concerning completing the diary. On Day 5, an image of the diary will be emailed by the family to the PACU for uploading into the secure REDCap database.

Control group families/ patients may call the physician's office postoperatively for pain support and a dose honey may be suggested for post-operative pain. These patients will be grouped into a separately and additional control patients will be enrolled until 50 control patients is achieved.

Eligibility criteria: Inclusion Criteria:

* english speaking
* children ages 5-17 years

Exclusion Criteria:

* any child with a genetic syndrome or developmental disability
* allergies to honey
* non-english speaking families

Primary outcomes:
measure: Numeric value of post-operative pain measured by FACES pain scale
timeFrame: Post-operative day 0 to post-operative day 5.
measure: Numeric value of post-operative pain measured by Visual Analog Scale (VAS) pain scale
timeFrame: Post-operative day 0 to post-operative day 5.
measure: Numeric value of post-operative nausea measured by Baxter Animated Retching Faces (BARF) scale
timeFrame: Post-operative day 0 to post-operative day 5.
Secondary outcomes:
measure: Beliefs and receptiveness of patient families on pain management measured with the catastrophizing scale
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Monroe Carell Jr. Children's Hospital at Vanderbilt
name: Patti Runyan, DNP
role: STUDY_DIRECTOR
References: