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Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery

Primary Purpose

Tonsillectomy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Honey
Standard of Care
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tonsillectomy focused on measuring honey, pediatrics, post-operative, pain, nausea, tonsillectomy, complimentary and alternative medicine

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Honey Intervention

Arm Description

The first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic).

Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen.

Outcomes

Primary Outcome Measures

Numeric value of post-operative pain measured by FACES pain scale
The post-operative pain is measured by the self-reported FACES pain scale. The range of scores is from 0-10. 0 (smiling face = no pain) and 10 (crying face) = worst pain ever. This scale is used by patients who are developmentally able, ages 5-9.
Numeric value of post-operative pain measured by Visual Analog Scale (VAS) pain scale
The VAS uses a horizontal 10cm line with the extremes of "no pain at all" and "worst pain imaginable". The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. This scale is used by patients who are developmentally able, ages 10-17.
Numeric value of post-operative nausea measured by Baxter Animated Retching Faces (BARF) scale
Baxter Animated Retching Faces (BARF) scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).

Secondary Outcome Measures

Beliefs and receptiveness of patient families on pain management measured with the catastrophizing scale
Families will be given a catastrophizing questionnaire to complete to understand their feelings about caring for their child in pain post-operatively. It is a 5 point likert scale that asks participants to select the word that best reflects how strongly they have each questionnaire thought (statement) when their child is in pain, such as 'When my child is in pain, I worry all the time about whether the pain will end', not at all to extremely.

Full Information

First Posted
May 27, 2021
Last Updated
July 1, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04910919
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
competing study started with same participants
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillectomy
Keywords
honey, pediatrics, post-operative, pain, nausea, tonsillectomy, complimentary and alternative medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
The first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic).
Arm Title
Honey Intervention
Arm Type
Experimental
Arm Description
Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen.
Intervention Type
Dietary Supplement
Intervention Name(s)
Honey
Intervention Description
Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
The first 50 participants will receive treatment as usual (alternating weight-based dosing of acetaminophen and ibuprofen with a PRN three-day supply of opioid analgesic).
Primary Outcome Measure Information:
Title
Numeric value of post-operative pain measured by FACES pain scale
Description
The post-operative pain is measured by the self-reported FACES pain scale. The range of scores is from 0-10. 0 (smiling face = no pain) and 10 (crying face) = worst pain ever. This scale is used by patients who are developmentally able, ages 5-9.
Time Frame
Post-operative day 0 to post-operative day 5.
Title
Numeric value of post-operative pain measured by Visual Analog Scale (VAS) pain scale
Description
The VAS uses a horizontal 10cm line with the extremes of "no pain at all" and "worst pain imaginable". The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. This scale is used by patients who are developmentally able, ages 10-17.
Time Frame
Post-operative day 0 to post-operative day 5.
Title
Numeric value of post-operative nausea measured by Baxter Animated Retching Faces (BARF) scale
Description
Baxter Animated Retching Faces (BARF) scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
Time Frame
Post-operative day 0 to post-operative day 5.
Secondary Outcome Measure Information:
Title
Beliefs and receptiveness of patient families on pain management measured with the catastrophizing scale
Description
Families will be given a catastrophizing questionnaire to complete to understand their feelings about caring for their child in pain post-operatively. It is a 5 point likert scale that asks participants to select the word that best reflects how strongly they have each questionnaire thought (statement) when their child is in pain, such as 'When my child is in pain, I worry all the time about whether the pain will end', not at all to extremely.
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patti Runyan, DNP
Organizational Affiliation
Monroe Carell Jr. Children's Hospital at Vanderbilt
Official's Role
Study Director
Facility Information:
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery

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