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Opioids + Steroids for Postoperative Pain in Children

Phase 4
Waitlist Available
Led By Eileen Raynor, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 4-17 years at time of surgery
Scheduled for tonsillectomy or adenotonsillectomy surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-op
Awards & highlights

Study Summary

This trial will help determine if adding a post-operative course of oral dexamethasone to the standard of care pain control regimen can help decrease opioid usage in pediatric patients undergoing adenotonsillectomy or tonsillectomy.

Who is the study for?
This trial is for children aged 4-17 scheduled for tonsil removal surgery who are not pregnant, breastfeeding, or have conditions like Down Syndrome, developmental delays, G-tube presence, steroid contraindications (like diabetes), recent steroid use, immune deficiencies or active infections.Check my eligibility
What is being tested?
The study aims to see if giving oral dexamethasone steroids after tonsil surgery affects opioid painkiller use in kids. Participants will either get a post-op course of steroids plus standard pain meds or just the standard meds and track their pain and medication usage.See study design
What are the potential side effects?
Potential side effects from dexamethasone may include increased appetite, mood changes, stomach upset, trouble sleeping and higher risk of infection. Opioids can cause nausea, vomiting, constipation, drowsiness and respiratory depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 4 and 17 years old and need surgery.
Select...
I am scheduled for surgery to remove my tonsils or both my tonsils and adenoids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid use
change in pain score
Secondary outcome measures
Number of post-operative complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dexamethasone plus analgesicsExperimental Treatment2 Interventions
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Group II: analgesics aloneActive Control1 Intervention
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Analgesics
2018
Completed Phase 4
~650
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,045 Total Patients Enrolled
1 Trials studying Postoperative Pain
1,200 Patients Enrolled for Postoperative Pain
Eileen Raynor, MDPrincipal InvestigatorDuke Health

Media Library

Analgesics Clinical Trial Eligibility Overview. Trial Name: NCT04541147 — Phase 4
Postoperative Pain Research Study Groups: Dexamethasone plus analgesics, analgesics alone
Postoperative Pain Clinical Trial 2023: Analgesics Highlights & Side Effects. Trial Name: NCT04541147 — Phase 4
Analgesics 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541147 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this trial exclude anyone under the age of 20?

"This trial is testing the efficacy of a new medication for children aged 4 to 17. Out of the 1,067 active clinical trials, this is one of 154 that specifically looks at minors and 913 that focus on senior citizens."

Answered by AI

Are there any particular medical conditions which would make somebody ineligible for this study?

"This study is open to children aged 4-17 who will be undergoing tonsillectomy or adenotonsillectomy surgery and are experiencing pain. Up to 60 participants will be enrolled."

Answered by AI

Has the FDA cleared any drugs in the analgesics category?

"Analgesics have already been approved for medical use, so they received a score of 3."

Answered by AI

How many people are registered to participate in this experiment?

"Unfortunately, this trial is no longer looking for participants. The listing was created on April 14th, 2021 and was last updated on May 26th, 2022. However, there are 539 other trials for patients with pain, postoperative and 575 studies for Analgesics that are currently recruiting."

Answered by AI

What type of pain does Analgesics typically help to alleviate?

"Ophthalmia, sympathetic is most commonly treated with Analgesics. Analgesics is also effective at treating other conditions like eye, branch retinal vein occlusion, and macular edema."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
2021. "Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04541147.
~6 spots leftby Apr 2025
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