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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
2,381 Previous Clinical Trials
3,427,689 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
~6 spots leftby Jun 2025
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