Treatment for Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh, Pittsburgh, PA
Disease+1 More
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.

Eligible Conditions

  • Disease
  • PPAP

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Post-operative up to 1-year

Year 1
Look at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
Look at genetic factors predisposing children to postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV) at genetic factors predisposing children to inadequate surgical pain relief with oxycodone
Immediately post-surgery
Look at genetic factors predisposing children to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)
Post-operative up to 1-year
Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain (CPSP) up to 1-year post-surgery
Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery
Day 2
Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in children to see if specific variants correlate with a need for lower or higher doses of analgesic

Trial Safety

Trial Design

0 Treatment Group

300 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-operative up to 1-year
Closest Location: University of Pittsburgh · Pittsburgh, PA
Photo of University of Pittsburgh Medical Center  1Photo of University of Pittsburgh Medical Center  2Photo of University of Pittsburgh Medical Center 3
2004First Recorded Clinical Trial
25 TrialsResearching Disease
647 CompletedClinical Trials

Who is running the clinical trial?

Senthilkumar SadhasivamLead Sponsor
4 Previous Clinical Trials
2,600 Total Patients Enrolled
1 Trials studying Disease
300 Patients Enrolled for Disease
National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,179 Total Patients Enrolled
200 Trials studying Disease
1,019,239 Patients Enrolled for Disease
Senthilkumar Sadhasivam, MD, MPHPrincipal InvestigatorUniversity of Pittsburgh
4 Previous Clinical Trials
3,048 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are prescribed opioids at discharge.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.