Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients

NCT02044497 | Recruiting Phase 4 DMC

• 1 other identifier: IRB-P00006691
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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. We would like to find out more about how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, we would like to give oxycodone to surgical patients at Boston Children's Hospital then measure its metabolic activity and also perform a genetic analysis. The genetic testing is specifically to analyze the following genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4), which represent the differences in cytochrome P450 metabolism of oxycodone.

Conditions

Pediatric Surgical Patient

Keywords

pharmacokinetics; pharmacogenomics; oral oxycodone; pediatric surgical patients

Outcome Measures

Primary Outcomes (1)

• Oxycodone, oxymorphone, noroxymorphone and noroxycodone serum levels

  Oxycodone, oxymorphone, noroxymorphone and noroxycodone levels, at 10 time points, will be used to determine the single-dose Pharmacokinetics (PK) metric.

  The 10 samples will be drawn at the following time points: 8 blood samples will be taken at 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient along other 2 samples at approximately either 8 and 12 or 10 and 24 hours post-dose.

Study Arms (1)

oral oxycodone

EXPERIMENTAL

An orogastric tube will be placed in the stomach (placement verified by routine accepted clinical guidelines) under anesthesia as is part of standard routine clinical care to remove gastric contents. The same orogastric tube will be used for intragastric liquid oxycodone administration in a dose of 0.1 mg/kg before the surgical incision. This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical dosing guidelines at Boston Children's Hospital.

Drug: oral oxycodone

Interventions

oral oxycodone DRUG

oral oxycodone

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A total of 68 generally healthy, opioid-naive children, aged 0-6 years, scheduled as in-patient surgery for ventriculoperitoneal shunt placement/revision or Craniotomy (Neurosurgery service), Cleft lip/palate repair (plastic surgery service) and hypospadias repair or ureteral urethral reimplantation (genitourinary surgery service) will be enrolled in the study.

You may not qualify if:

• Children will be excluded if they are currently taking any medications which are CYP3A4 or CYP2D6 inhibitors/inducers or have a history of allergy or hypersensitivity to oxycodone, have any condition that might interfere with GI absorption, distribution, hepatic metabolism or renal excretion of r oxycodone, or a diagnosis of sleep apnea or impaired respiratory reserve.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Patcharee Sriswasdi, MD

  Boston Children Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Dube, MS, BSN, RN

CONTACT

617-355-6185; Christine.Dube@childrens.harvard.edu

Rachel Bernier, BS, MPH

CONTACT

857-218-5348; Rachel.Bernier@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (1)