Understanding how oxycodone works in young surgical patients
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
This study is testing how the pain medication oxycodone works in young children having surgery to see if their genes affect how the drug is processed in their bodies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | N/A to 6 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02044497 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics and pharmacogenomics of oral oxycodone in pediatric surgical patients at Boston Children's Hospital. It aims to understand how oxycodone is absorbed, metabolized, and excreted in children, particularly focusing on genetic factors that may affect drug metabolism. The study will involve administering oxycodone to opioid-naive children aged 0-6 years undergoing specific surgeries and measuring its metabolic activity alongside genetic analysis of relevant enzymes. This research seeks to establish a clearer understanding of oxycodone's effects in the pediatric population to optimize pain management.
Who should consider this trial
Good fit: Ideal candidates are generally healthy, opioid-naive children aged 0-6 years scheduled for specific surgical procedures.
Not a fit: Patients currently taking medications that affect CYP3A4 or CYP2D6 enzymes or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective pain management strategies for children undergoing surgery.
How similar studies have performed: While studies on oxycodone in adults are common, this specific investigation into pediatric pharmacokinetics and pharmacogenomics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Boston, Massachusetts
- Boston Children Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Patcharee Sriswasdi, MD — Boston Children Hospital
- Study coordinator: Christine Dube, MS, BSN, RN
- Email: Christine.Dube@childrens.harvard.edu
- Phone: 617-355-6185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.