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Standard of Care for Tonsillectomy

N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks
Awards & highlights

Study Summary

This study is evaluating whether a combination of acetaminophen and ibuprofen with honey can reduce postoperative pain and nausea in children following tonsillectomy.

Eligible Conditions
  • Tonsillectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric value of post-operative nausea measured by Baxter Animated Retching Faces (BARF) scale
Numeric value of post-operative pain measured by FACES pain scale
Numeric value of post-operative pain measured by Visual Analog Scale (VAS) pain scale
Secondary outcome measures
Beliefs and receptiveness of patient families on pain management measured with the catastrophizing scale

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Honey InterventionExperimental Treatment2 Interventions
Participants 51 - 100 will receive the standard of care treatment as usual plus 1 tsp of honey with every dose of acetaminophen.
Group II: Standard of CareActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Honey
2019
Completed Phase 3
~1530

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,192 Total Patients Enrolled
1 Trials studying Tonsillectomy
230 Patients Enrolled for Tonsillectomy
Patti Runyan, DNPStudy DirectorMonroe Carell Jr. Children's Hospital at Vanderbilt

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery
Patti Runyan 2022. "Here's the Buzz: Evaluating Pediatric Post Op Pain and Nausea Following Tonsillectomy Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04910919.
~0 spots leftby Apr 2025
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