← Back to Search

Opioid Analgesic

Oxycodone for Post-Operative Pain in Children

Phase 4

Recruiting

Led By Patcharee Sriswasdi, MD, MPH

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is investigating the effects of oxycodone on post-operative pain in children. Children will be given the drug at different times during surgery to see how it is metabolized and to what extent it relieves pain.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests how general anesthesia affects the body's handling of liquid oxycodone in children. It compares the drug's effects when given at the start versus the end of anesthesia during surgery. The trial also includes genetic testing to understand different responses.See study design

What are the potential side effects?

While side effects are not explicitly listed here, common ones associated with oxycodone include nausea, vomiting, constipation, drowsiness and respiratory depression. Genetic differences may cause some children to experience more intense side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years .

General Anesthesia

Secondary outcome measures

the effect of general anesthesia on maximum plasma oxycodone level in patients age 2-5 years

the effect of general anesthesia on maximum plasma oxycodone level in patients age 6-8 years

the effect of general anesthesia on oxycodone absorption in patients age 2-5 years

+9 more

Trial Design

4Treatment groups

Active Control

Group I: Age 2-5 years-Before GAActive Control1 Intervention

The group will include 25 patients (children 2-5 years old). In this group the children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube before the procedure at the beginning of general anesthesia (after intubation).

Group II: Age 2-5 years-After GAActive Control1 Intervention

In this group 25 children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube after the procedure at the end of general anesthesia (before extubation).

Group III: Age 6-8 years-Before GAActive Control1 Intervention

The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally before the surgery in pre-op holding.

Group IV: Age 6-8 years-After GAActive Control1 Intervention

The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally after surgery in the Post Anesthesia Care Unit (PACU).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,690 Total Patients Enrolled

Patcharee Sriswasdi, MD, MPHPrincipal Investigator - Boston Children's Hospital

Boston Children's Hospital, Chmc Anesthesia Foundation Inc

2 Previous Clinical Trials

588 Total Patients Enrolled

Media Library

Oxycodone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03054831 — Phase 4

Oxycodone Research Study Groups: Age 2-5 years-Before GA, Age 2-5 years-After GA, Age 6-8 years-Before GA, Age 6-8 years-After GA

Oxycodone Clinical Trial 2023: Oxycodone Highlights & Side Effects. Trial Name: NCT03054831 — Phase 4

Oxycodone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03054831 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies for participation in this experiment?

"To be suitable for this trial, candidates must have a documented history of oxycodone use and are within the age range of two to eight years old. The study aims to enroll around 40 participants in total."

Answered by AI

Has the federal agency approved Age 6-8 years-Before GA for consumer use?

"There is a wealth of evidence indicating that Age 6-8 years-Before GA has an acceptable safety profile, consequently it received the highest rating of 3."

Answered by AI

Are individuals over 30 years of age included in this trial's recruitment process?

"As stipulated in the trial's eligibility criteria, children aged between 2 and 8 are welcome to participate."

Answered by AI

What is the purpose of this medical experiment?

"This investigation will assess the influence of general anaesthesia on plasma oxycodone levels in children aged 2-5 over a period spanning up to 24 weeks. Secondary objectives are assessing Cmax and AUC for oxycodone, as well as AUC for noroxycodone across different age groups (2-5, 6-8) while factoring in pharmacogenomics."

Answered by AI

Are there any existing studies that focus on children between the ages of 6 and 8 prior to entering grade school?

"At the moment, 25 separate clinical trials are actively exploring Age 6-8 years-Before GA. Out of those studies, six have reached Phase 3 and majority of them take place in Philadelphia, Pennsylvania with an additional 28 trial sites across the country."

Answered by AI

Are there any vacancies remaining in this trial for participants?

"This trial, which was initially made available on July 8th 2019, is currently recruiting participants. Clinicaltrials.gov records the last update to have taken place on August 21st 2022."

Answered by AI

What is the participant count of this research endeavor?

"Affirmative. Clinicaltrials.gov records demonstrate that this medical research project, which was first publicized on July 8th 2019, is accepting new enrollees. Approximately 40 individuals are being sought at a solitary site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

Patcharee Sriswasdi 2019. "The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03054831.

All > Anesthesia