Oxycodone for Post-Operative Pain in Children

Overseen By Christine Dube, MS, BSN

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Children's Hospital

Must not be taking: CYP3A4/2D6 inhibitors/inducers

Disqualifiers: Allergy to oxycodone, Gastrointestinal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the pain medication oxycodone works in children after surgery. Researchers focus on how the timing of the drug's administration during anesthesia (either before or after surgery) affects its absorption and metabolism. They aim to determine if genetic differences cause some children to process the drug differently, potentially leading to more side effects. Children aged 2-8 scheduled for specific surgeries, such as hypospadias repair, and who have not used opioids before, might be eligible to participate. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to enhance understanding of its benefits for more patients.

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.

What is the safety track record for oxycodone?

Research has shown that oxycodone is often used to manage post-surgery pain in children and is usually well-tolerated. One study found that controlled-release oxycodone effectively manages pain in this context. However, side effects can occur, with constipation and nausea being common.

Monitoring children taking oxycodone for possible side effects is important. These side effects can include changes in blood pressure and heart rate. There is also a small risk of developing a dependency on opioids. Research indicates that about 5% of teenagers using opioids for post-surgery pain might continue using them longer than necessary.

The FDA has approved oxycodone for pain management in various situations, providing some safety assurance. However, genetic differences can cause children to process the drug differently, potentially leading to varied side effects. Discussing potential risks and benefits with healthcare providers is crucial to making the best decision for a child's care. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using oxycodone for post-operative pain in children because it explores different timing and methods of delivery that could optimize pain management. Unlike standard treatments that might not specify precise timing related to anesthesia, this approach investigates administering liquid oxycodone either before or after general anesthesia, potentially enhancing its effectiveness. Additionally, by examining its use in both younger (ages 2-5) and slightly older children (ages 6-8), this trial aims to tailor pain management strategies to specific age groups, which could improve comfort and recovery in pediatric patients.

What is the effectiveness track record for oxycodone in treating post-operative pain in children?

Research has shown that oxycodone is a good choice for managing pain in children after surgery. Studies have found it effective and safe for pain relief, especially after surgeries like spinal fusion. As a strong painkiller, oxycodone is useful for moderate to severe pain. In this trial, researchers will divide children into groups based on age and timing of administration to assess oxycodone's effectiveness. Compared to other medications like tramadol, oxycodone-based treatments have effectively reduced pain. Understanding that children may process the drug differently is crucial, so knowing each child's response is important. Overall, oxycodone has a proven track record for helping children manage post-surgical pain. ^{1 2 3 6 7}

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

I am between 2-8 years old, need specific urinary tract surgery, and haven't taken opioids.

Exclusion Criteria

Known history of allergy to oxycodone

Speak a language other than English

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples analyzed for pharmacokinetic parameters

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxycodone

Trial Overview 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.

How Is the Trial Designed?

Group I: Age 2-5 years-Before GA Active Control 1 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 GA Active Control 1 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 GA Active Control 1 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 GA Active Control 1 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).

Oxycodone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as OxyContin for:

• Moderate to severe pain
• Chronic pain

Approved in European Union as OxyContin for:

• Severe pain
• Cancer pain

Approved in Canada as OxyContin for:

• Moderate to severe pain

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a study of 79 patients undergoing thumb carpometacarpal arthroplasty or distal radius ORIF, the combination of oxycodone, acetaminophen, and ketorolac showed a trend towards better postoperative pain control and reduced opioid usage compared to other regimens.

Although not statistically significant, the group receiving oxycodone, acetaminophen, and ketorolac experienced fewer complications, suggesting that this combination may enhance safety and efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Modal Pain Control in Ambulatory Hand Surgery. Harrison, RK., DiMeo, T., Klinefelter, RD., et al.[2018]

Oxycodone, a commonly used opioid for moderate-to-severe pain, has a higher bioavailability and longer half-life compared to oral morphine, which is important for its effective use in various patient populations.

The pharmacokinetics of oxycodone can vary significantly among individuals, especially in special populations like children and those with liver or renal failure, highlighting the need for careful dosing to maximize pain relief while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics of oxycodone. Lugo, RA., Kern, SE.[2022]

In a study of 166 children undergoing endoscopic plasma total adenotonsillectomy, preemptive analgesia with a low dose of oxycodone (0.1 mg/kg) significantly reduced postoperative pain compared to standard sufentanil treatment.

The use of preemptive oxycodone resulted in lower serum c-fos levels and better pain management outcomes, as indicated by lower Pediatric Anesthesia Emergence Delirium (PAED) scores and FLACC scores at 24 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxycodone preemptive analgesia after endoscopic plasma total adenotonsillectomy in children: A randomized controlled trial. Wu, J., Gui, Q., Wang, J., et al.[2022]

The new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) was found to be more effective than a higher dose of oxycodone alone in managing acute pain after oral surgery, based on a study of 141 patients.

This combination not only provided faster pain relief but also resulted in fewer treatment-related side effects, highlighting its potential as a safer alternative for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. Gammaitoni, AR., Galer, BS., Bulloch, S., et al.[2019]

A study of 62 pediatric patients (ages 10-19) showed that controlled-release oxycodone (oxycodone-CR) is safe and effective for managing pain after spinal fusion surgery, with pain scores decreasing from 4.2 to 3.7 out of 10.

Patients transitioned to oxycodone-CR after the immediate postoperative period, using it for an average of 13.3 days, and experienced common side effects like dizziness, constipation, and nausea, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled-release oxycodone for the management of pediatric postoperative pain. Czarnecki, ML., Jandrisevits, MD., Theiler, SC., et al.[2019]

Intravenous oxycodone provides adequate postoperative pain relief in pediatric patients, similar to tramadol, but with less sedation and a shorter recovery time in the post-anesthesia care unit (PACU).

Both oxycodone and tramadol had comparable side effects, primarily nausea and vomiting, indicating that oxycodone may be a safer alternative for managing acute postoperative pain in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxycodone vs. tramadol in postoperative parent-controlled intravenous analgesia in children: a prospective, randomized, double-blinded, multiple-center clinical trial. Li, S., Xiong, H., Jia, Y., et al.[2023]

In a study involving 66 children aged 6-18 with orthopedic injuries, oxycodone, ibuprofen, and their combination all effectively reduced pain, but there were no significant differences in pain relief among the three treatment groups.

The combination of oxycodone and ibuprofen led to more adverse effects, suggesting that using either medication alone is preferable to minimize side effects while still providing effective pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children. Koller, DM., Myers, AB., Lorenz, D., et al.[2013]

In a study involving 22 pediatric patients aged 5-14, both oral transmucosal fentanyl citrate (OTFC) and oral oxycodone provided effective pain relief during outpatient burn wound care, with no significant side effects reported.

OTFC was preferred for its better taste, making it a more palatable option for children, while both medications demonstrated similar safety and efficacy profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of oral transmucosal fentanyl citrate and oral oxycodone for pediatric outpatient wound care. Sharar, SR., Carrougher, GJ., Selzer, K., et al.[2019]

Oral oxycodone is effective for managing acute postoperative pain, showing superior analgesic efficacy compared to placebo and comparable or better pain relief than intravenous opioids in various surgical procedures, including knee arthroplasty and laparoscopic surgeries.

Patients using oral oxycodone experienced fewer side effects than those on other opioids, did not have prolonged hospital stays, and had lower overall drug costs, making it a safe and reasonable alternative for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. Cheung, CW., Ching Wong, SS., Qiu, Q., et al.[2018]

Providing an oxycodone information sheet to parents significantly improved their satisfaction and knowledge regarding pain management after their child's tonsillectomy, leading to better pain control, especially noted on day 5 post-surgery (p<0.05).

The study highlights the importance of educational materials in enhancing postoperative analgesia management, suggesting that such information sheets should be routinely given to parents to ensure safer and more effective pain relief for children after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving postoperative tonsillectomy pain management in children--a double blinded randomised control trial of a patient analgesia information sheet. Bailey, L., Sun, J., Courtney, M., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0885392404000028

Controlled-release oxycodone for the management of ... The purpose of this study was to assess the safety and efficacy of oxycodone-CR in the management of children's pain following spinal fusion surgery. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03495388

PG and PK of Oxycodone to Personalize Post-op Pain ... The purpose of this research is to study serious immediate and long-term clinical problems from both surgical pain and oxycodone use in children and adolescents ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02054-8

Oxycodone vs. tramadol in postoperative parent-controlled ... In this study, we propose that oxycodone-based PCIA can provide postoperative pain relief in pediatric patients effectively and safely.

4. childrenshospital.org childrenshospital.org/clinical-trials/nct02044497

NCT02044497 Oxycodone is the most commonly used analgesic for the management of moderate and severe postoperative pain. The efficacy of Oxycodone as a potent opioid has ...

5. facs.org facs.org/for-patients/recovering-from-surgery/safe-pain-management/pediatric-pain-control/

Safe and Effective Pain Control After Surgery for Children ... Information on how to provide safe and effective pain control after surgery for children and teens .

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482226/

Oxycodone - StatPearls - NCBI Bookshelf - NIH Patients taking oxycodone require monitoring for the presence of constipation, pain relief, adverse effects, and appropriate usage. Their blood pressure, heart ...

7. publications.aap.org publications.aap.org/pediatrics/article/154/5/e2024068752/199482/Opioid-Prescribing-for-Acute-Pain-Management-in

Opioid Prescribing for Acute Pain Management in Children ... As many as 5% of adolescents who are exposed to opioids for postoperative analgesia may be at risk for persistent opioid use.39 Thus, the CPG ...