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Opioid

Short acting opioids: Fentanyl, Hydromorphone for Tonsillitis

Phase 2
Waitlist Available
Led By Lisa M Einhorn, MD
Research Sponsored by Duke University
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 up to 7 days post surgery
Awards & highlights

Study Summary

This trial will compare the use of different types of opioids to control pain following tonsillectomy surgery.

Eligible Conditions
  • Tonsillitis
  • Procedural Pain
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total amount of opioid medications administered
Secondary outcome measures
Evaluation of participant's pain as measured by Numeric Pain Rating Scale
Evaluation of participant's pain as measured by Parent Post operative Pain Measure (PPPM)
NIH PROMIS Parent Proxy Report Scale
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Short acting opioids: Fentanyl, HydromorphoneActive Control1 Intervention
Group II: Long Acting Opioid: MethadoneActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,419,060 Total Patients Enrolled
Lisa M Einhorn, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
42 Total Patients Enrolled

Frequently Asked Questions

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

Can elderly people take part in this experiment?

"Children aged 3 to 17 years old may be eligible to participate in this study, based on the inclusion criteria."

Answered by AI

Are patients needed for this research project at this time?

"This research is looking for participants and was last updated on the 8th of April, 2022 according to clinicaltrials.gov."

Answered by AI

How many people can be a part of this research project at most?

"That is correct, the online information portal clinicaltrials.gov has verified that this study is looking for 60 individuals to take part in research trials at a single site. The original posting was on April 8th, 2022 and there have been no updates since then."

Answered by AI

Would I be able to help with this research by enrolling in the trial?

"Sixty patients that currently experience pain and meet the following age, procedure, and consent criteria are being enrolled in this clinical trial: 3-17 years old, scheduled for tonsillectomy +/- adenoidectomy, able to provide informed consent / assent."

Answered by AI

What are the FDA's current thoughts on short-acting opioids such as Fentanyl and Hydromorphone?

"While there is some data backing the safety of short acting opioids like Fentanyl and Hydromorphone, there is no evidence yet to support their efficacy. Our team has given it a 2."

Answered by AI

What is the primary goal of this research?

"The primary outcome of this study, which will be administered over a period of 7 days post-surgery, is to measure the total amount of opioids consumed by patients in the long-acting opioid group. Secondary outcomes include assessing pain levels in the short-acting opioid group using the Numeric Pain Rating Scale (NPRS), measuring patient satisfaction and behaviour scores in the long-acting opioid group using the NIH PROMIS Parent Proxy Report Scale, and finally evaluating pain levels in the long-acting opioid group using NPRS."

Answered by AI
~22 spots leftby Apr 2025