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Opioid Analgesic
Oral Oxycodone for Pediatric Post-Surgical Pain
Phase 4
Recruiting
Led By Patcharee Sriswasdi, MD
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
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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the 10 samples will be drawn at the following time points: 8 blood samples will be taken at 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient along other 2 samples at approximately either 8 and 12 or 10 and 24 hours post-dose.
Awards & highlights
Study Summary
This trial will help researchers learn more about how the commonly prescribed painkiller oxycodone affects children by studying its metabolic activity and performing genetic testing.
Who is the study for?
This trial is for generally healthy children aged 0-6 who need in-patient surgery like shunt placement, craniotomy, cleft lip/palate repair, or genitourinary surgeries. They shouldn't have taken opioids before and can't join if they have issues with drug absorption/metabolism/excretion, are on certain other meds, allergic to oxycodone, or have breathing problems.Check my eligibility
What is being tested?
The study is testing how oral oxycodone works in the bodies of pediatric surgical patients at Boston Children's Hospital. It involves giving them oxycodone and then measuring its effects and how it's processed by their bodies. The study also includes genetic tests to see how variations in metabolism genes affect the drug's behavior.See study design
What are the potential side effects?
Oxycodone may cause side effects such as nausea, vomiting, constipation, drowsiness or mood changes. Since this trial includes genetic analysis for metabolism differences among kids (CYP2D6 & CYP3A4), some might experience more intense side effects due to faster metabolization.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is healthy, hasn't used opioids, and is having specific surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the 10 samples will be drawn at the following time points: 8 blood samples will be taken at 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient along other 2 samples at approximately either 8 and 12 or 10 and 24 hours post-dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the 10 samples will be drawn at the following time points: 8 blood samples will be taken at 30 minutes, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose in every patient along other 2 samples at approximately either 8 and 12 or 10 and 24 hours post-dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxycodone, oxymorphone, noroxymorphone and noroxycodone serum levels
Trial Design
1Treatment groups
Experimental Treatment
Group I: oral oxycodoneExperimental Treatment1 Intervention
An orogastric tube will be placed in the stomach (placement verified by routine accepted clinical guidelines) under anesthesia as is part of standard routine clinical care to remove gastric contents. The same orogastric tube will be used for intragastric liquid oxycodone administration in a dose of 0.1 mg/kg before the surgical incision. This weight-adjusted dose of 0.1 mg/kg is administered as per standard clinical dosing guidelines at Boston Children's Hospital.
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
760 Previous Clinical Trials
5,579,612 Total Patients Enrolled
Patcharee Sriswasdi, MDPrincipal Investigator - Boston Children Hospital
Boston Children's Hospital, Chmc Anesthesia Foundation Inc
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is not on any CYP3A4 or CYP2D6 affecting drugs and has no allergy to oxycodone.My child does not have sleep apnea or breathing problems.My child is healthy, hasn't used opioids, and is having specific surgery.My child does not have conditions affecting drug processing in their body.
Research Study Groups:
This trial has the following groups:- Group 1: oral oxycodone
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have signed up to participate in this clinical research?
"Affirmative. Clinicaltrials.gov describes this medical experiment as actively seeking participants, which was initially published on May 1st 2014 and recently updated on June 6th 2022. 68 volunteers are needed from one location for the study to be completed successfully."
Answered by AI
Are there any open enrollment opportunities for the current clinical trial?
"Clinicaltrials.gov states this clinical trial is actively recruiting participants, having been posted on May 1st 2014 and most recently revised on June 6th 2022."
Answered by AI
Has the Food and Drug Administration validated oral oxycodone for medical use?
"We have assigned a risk rating of 3 to oxycodone due to the fact it has been authorised by Phase 4 trials and thus there is solid evidence for its safety."
Answered by AI
Are there precedents of research utilizing oral oxycodone?
"Presently, there are 25 clinical trials in progress investigating the use of oral oxycodone. Of those, 6 are currently at Phase 3. Most of these trials can be found in Philadelphia but they exist across 28 different sites."
Answered by AI
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