Understanding how general anesthesia affects oxycodone in children
The Effect of General Anesthesia on Pharmacokinetics and Pharmacogenomics of Liquid Oxycodone in Pediatric Surgical Patients
PHASE4 · Boston Children's Hospital · NCT03054831
This study is testing how the timing of oxycodone given during surgery affects how children aged 2-8 process the medication, while also looking at how their genes might play a role.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 2 Years to 8 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03054831 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of liquid oxycodone in pediatric patients undergoing surgery at Boston Children's Hospital. It involves two groups of children aged 2-8 years who will receive oxycodone either at the beginning or the end of general anesthesia. The study aims to measure how the drug is absorbed, metabolized, and excreted, particularly focusing on genetic factors that may influence these processes. Blood samples will be taken for genetic analysis to understand variations in drug metabolism among participants.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-8 years scheduled for specific surgical procedures and who are opioid naive.
Not a fit: Patients currently taking CYP 3A4 or 2D6 inhibitors/inducers or with known allergies to oxycodone will 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 in relation to general anesthesia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients are scheduled for the following in-patient surgical procedures: * hypospadias repair * ureteral reimplantation * pyeloplasty (Genitourinary Surgery Service) and age between 2-8 years, and opioid naive, and not meet exclusion criteria Exclusion Criteria: * currently taking cytochrome P450(CYP) 3A4 or 2D6 inhibitors/inducers * known history of allergy to oxycodone * known gastrointestinal, hepatic, or renal dysfunction * known sleep apnea or impaired respiratory reserve * speak a language other than English
Where this trial is running
Boston, Massachusetts
- Boston Children Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Patcharee Sriswasdi, MD, MPH — Boston Children's Hospital
- Study coordinator: Patcharee Sriswasdi, MD, MPH
- Email: patcharee.sriswasdi@childrens.harvard.edu
- Phone: 617-355-7737
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.
Conditions: Liquid Oxycodone