RECRUITING

The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. The investigators would like to find out more about how general anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, the investigators would like to give oxycodone to surgical patients (group one will receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic activity and also perform a specific genetic analysis.

Official Title

The Effect of General Anesthesia on Pharmacokinetics and Pharmacogenomics of Liquid Oxycodone in Pediatric Surgical Patients

Quick Facts

Study Start:2019-07-08
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03054831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * hypospadias repair
  2. * ureteral reimplantation
  3. * pyeloplasty (Genitourinary Surgery Service) and age between 2-8 years, and opioid naive, and not meet exclusion criteria
  1. * currently taking cytochrome P450(CYP) 3A4 or 2D6 inhibitors/inducers
  2. * known history of allergy to oxycodone
  3. * known gastrointestinal, hepatic, or renal dysfunction
  4. * known sleep apnea or impaired respiratory reserve
  5. * speak a language other than English

Contacts and Locations

Study Contact

Patcharee Sriswasdi, MD, MPH
CONTACT
617-355-7737
patcharee.sriswasdi@childrens.harvard.edu
Christine Dube, MS, BSN
CONTACT
617-355-6185
christine.dube@childrens.harvard.edu

Principal Investigator

Patcharee Sriswasdi, MD, MPH
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Patcharee Sriswasdi, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-08
Study Completion Date2026-12

Study Record Updates

Study Start Date2019-07-08
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Liquid Oxycodone