What side effects are associated with this type of intervention?

Oxycodone, an opioid analgesic used for pain management, commonly causes side effects such as nausea, vomiting, constipation, dizziness, drowsiness, and headache. Serious side effects can include respiratory depression, hypotension, and potential for misuse or addiction. In children, the risk of side effects may be higher due to differences in drug metabolism.

What prior FDA approvals exist?

Oxycodone is an opioid analgesic that has been FDA-approved for the management of moderate to severe pain. It is commonly used in both immediate-release and controlled-release formulations. Immediate-release oxycodone is often prescribed for acute pain, such as post-operative pain, while controlled-release formulations are used for chronic pain conditions, including cancer-related pain and persistent pain associated with osteoarthritis. Related drugs include combination products like oxycodone with acetaminophen, which are also approved for pain management.

What other types of research exist?

Promising novel alternatives to oxycodone for pain management include: <ol> <li>Duloxetine: An SNRI effective for chronic pain, including low back pain, with additional benefits for patients with depression.</li> <li></li> </ol> Buprenorphine: A unique opioid with a ceiling effect on respiratory depression, making it safer for long-term use. 3. Local glucocorticoid injections: Effective for targeted pain relief in conditions like enthesopathy. 4. Tumor necrosis factor inhibitors: Shown to improve pain scores in patients with conditions like DISH. 5. Acetyl-L-carnitine: Demonstrated pain reduction in neuropathic conditions. These alternatives offer varied mechanisms of action and may provide effective pain relief with potentially fewer side effects compared to traditional opioids.

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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

Must not have

Known sleep apnea or impaired respiratory reserve

Known gastrointestinal, hepatic, or renal dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

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

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I have been diagnosed with sleep apnea or have breathing issues.

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I have known issues with my digestive system, liver, or kidneys.

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I am currently on medication that affects liver enzymes.

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

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

Primary study objectives

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

General Anesthesia

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

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).

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oxycodone is an opioid analgesic that alleviates pain by binding to mu-opioid receptors in the central nervous system, inhibiting pain pathways, and altering pain perception. This mechanism is significant for patients as it provides effective pain relief but also necessitates careful management to avoid side effects like sedation, constipation, and dependency. The trial studying Oxycodone under general anesthesia in children aims to optimize dosing and minimize adverse effects, ensuring safer and more effective pain management in pediatric patients.

Short-Acting Opioids Are Associated with Comparable Analgesia to Long-Acting Opioids in Patients with Chronic Osteoarthritis with a Reduced Opioid Equivalence Dosing.