Methadone vs Short-Acting Opioids for Cleft Palate

(OPAL-Cleft Trial)

Overseen By Lisa M. Einhorn, M.D.

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Chronic kidney, liver disease, 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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is methadone generally safe for humans?

Methadone is considered relatively safe for managing chronic pain and opioid dependency, but it requires careful dosing and monitoring due to risks like potential overdose and heart rhythm issues. In pregnant women, methadone can affect newborns, leading to conditions like neonatal abstinence syndrome, but it is still used as a treatment option. Safety in children exposed to methadone during pregnancy shows no more impairment in growth than other high-risk groups. ^{1 2 3 4 5}

How does the drug Methadone differ from other drugs for cleft palate pain management?

Methadone is unique because it is a long-acting opioid, which means it can provide more consistent pain relief over time compared to short-acting opioids like fentanyl or hydromorphone. This could potentially reduce the frequency of dosing and help manage pain more effectively in patients undergoing cleft palate repair. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.

Research Team

Lisa M. Einhorn, M.D.

Principal Investigator

Duke University

Eligibility Criteria

This trial is for infants and young children aged 6 months to 4 years who are undergoing primary cleft palate repair surgery. Parents or legal guardians must provide consent. Children with chronic kidney or liver disease, those needing additional procedures under general anesthesia, or planned PICU admissions after surgery cannot participate.

Inclusion Criteria

Signed informed consent by parent or legal guardian

I have had surgery to repair a cleft palate.

I am between 6 months and 4 years old.

Exclusion Criteria

Any patient ineligible for study participation at the discretion of the investigators

My child is scheduled for a stay in the Pediatric Intensive Care Unit.

I have a history of chronic kidney or liver disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Participants receive either methadone or fentanyl/hydromorphone as perioperative analgesics during cleft palate surgery

Up to 1 day

In-hospital stay

Postoperative Monitoring

Participants are monitored for opioid use and pain intensity using the FLACC pain scale

Up to 7 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days

Treatment Details

Interventions

• Fentanyl/Hydromorphone
• Methadone hydrochloride

Trial Overview The study compares two types of pain medications: short-acting opioids (fentanyl/hydromorphone) versus long-acting opioids (methadone), to manage pain in children after cleft palate surgery. It aims to determine which provides better postoperative pain control.

Participant Groups

Group I: Methadone Active Control 1 Intervention

Methadone 0.2-0.25 mg/kg actual body weight

Group II: Fentanyl/Hydromorphone Active Control 1 Intervention

Fentanyl/Hydromorphone per routine care

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

In a study comparing neonates of opioid-dependent women treated with buprenorphine versus methadone, buprenorphine-exposed neonates required less opioid medication for neonatal abstinence syndrome (NAS) and had shorter hospital stays, indicating a potential safety and efficacy advantage.

The study found that 20% of buprenorphine-exposed neonates were treated for NAS compared to 45.5% of methadone-exposed neonates, suggesting that buprenorphine may be as effective as methadone in managing NAS outcomes when treatment begins in the second trimester.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome. Jones, HE., Johnson, RE., Jasinski, DR., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Methadone for cancer pain. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Fetal and postnatal growth of children born to narcotic-dependent women. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Methadone, Pierre Robin sequence and other congenital anomalies: case-control study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Prescribing methadone for pain management in end-of-life care. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Preemptive analgesic effectiveness of single dose intravenous ibuprofen in infants undergoing cleft palate repair: a randomized controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Is the Use of Opioids Safe after Primary Cleft Palate Repair? A Systematic Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical analgesic equivalence for morphine and hydromorphone with prolonged PCA. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Institutional Trends in Opioid Prescribing and Utilization after Primary Cleft Lip and Palate Repair. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Parent-controlled analgesia in children undergoing cleft palate repair. [2021]