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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

Must not have

Children will be excluded if they are currently taking any medications which are CYP3A4 or CYP2D6 inhibitors/inducers or have a history of allergy or hypersensitivity to oxycodone

Children will be excluded if they have a diagnosis of sleep apnea or impaired respiratory reserve.

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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My child is healthy, hasn't used opioids, and is having specific surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child is not on any CYP3A4 or CYP2D6 affecting drugs and has no allergy to oxycodone.

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My child does not have sleep apnea or breathing problems.

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My child does not have conditions affecting drug processing in their body.

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.

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oxycodone, oxymorphone, noroxymorphone and noroxycodone serum levels

Awards & Highlights

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.

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.

0 / 4Eligibility criteria met