The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Anesthetics; Oxycodone

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