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

NCT ID: NCT04910919

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-07-31

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.

Conditions

Tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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).

Honey Intervention

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

Group Type: EXPERIMENTAL

Honey

Intervention Type: DIETARY_SUPPLEMENT

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

Standard of Care

Intervention Type: OTHER

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).

Interventions

Honey

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

Standard of Care

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Patti Runyan

Administrative Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patti Runyan, DNP

Role: STUDY_DIRECTOR

Monroe Carell Jr. Children's Hospital at Vanderbilt

Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

Buzz Study

Identifier Type: -

Identifier Source: org_study_id