Oxycodone for Post-Operative Pain in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies how oxycodone, a pain medication, is processed in young children undergoing surgery. Researchers aim to understand how anesthesia affects the drug's absorption and metabolism, and how genetic differences might influence its effectiveness and side effects. Oxycodone is a semisynthetic opioid used for pain management, known for its prolonged duration of action and greater potency compared to morphine.
Do I need to stop my current medications for the trial?
Yes, you must stop taking any medications that are cytochrome P450 (CYP) 3A4 or 2D6 inhibitors or inducers to participate in this trial.
Is oxycodone safe for children after surgery?
How is the drug oxycodone unique for treating post-operative pain in children?
What data supports the effectiveness of the drug oxycodone for post-operative pain in children?
Research shows that oral oxycodone is effective for managing acute postoperative pain, as it is a commonly used opioid for such conditions. Additionally, a study found that oxycodone was effective in managing pain for pediatric outpatient wound care, indicating its potential usefulness in similar settings.348910
Who Is on the Research Team?
Patcharee Sriswasdi, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children aged 2-8 who are scheduled for specific in-patient surgeries (like hypospadias repair) at Boston Children's Hospital, have not used opioids before, and do not take certain other drugs or have liver, kidney, gastrointestinal issues, sleep apnea or allergies to oxycodone.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 0.1 mg/kg of liquid oxycodone either before or after general anesthesia, with blood samples taken at 10 time points to study pharmacokinetics and pharmacogenomics
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood samples analyzed for pharmacokinetic parameters
What Are the Treatments Tested in This Trial?
Interventions
- Oxycodone
Oxycodone is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor