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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to manage pain after cleft palate surgery in young children. It compares two types of pain medications: short-acting opioids like fentanyl and hydromorphone, and the long-acting opioid methadone. Children who have undergone cleft palate surgery and do not have chronic kidney or liver disease are suitable candidates. The goal is to determine which medication offers better pain relief for these children. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

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

What is the safety track record for these treatments?

Research has shown that methadone is generally safe for managing long-term pain and opioid addiction, but it requires careful dosing and monitoring due to potential risks. The FDA has already approved methadone for other uses, indicating it is well-tolerated when used properly.

Studies have found that fentanyl and hydromorphone can cause side effects like vomiting and low oxygen levels in the blood. However, these issues are known and can be managed. Both drugs are commonly used in hospitals for pain relief, so doctors are familiar with their effects and how to manage them.

This study compares how these treatments work for children after cleft palate surgery. Both treatment options have been used before and are well-understood by doctors, which helps ensure patient safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for cleft palate pain management because they offer potentially better alternatives to standard short-acting opioids. Methadone is unique because it is a long-acting opioid, which means it can provide more stable pain control with less frequent dosing compared to quick-acting opioids like fentanyl and hydromorphone. This could lead to improved patient comfort and reduced risk of opioid misuse. On the other hand, the combination of fentanyl and hydromorphone remains a flexible option, allowing for tailored pain relief. Together, these treatments could transform how pain is managed in cleft palate surgeries, highlighting their potential benefits over existing care standards.

What evidence suggests that this trial's treatments could be effective for cleft palate pain management?

This trial will compare Methadone with Fentanyl/Hydromorphone for pain management after cleft palate surgery. Research has shown that methadone can provide more consistent pain relief due to its longer duration in the body, potentially requiring fewer doses. In contrast, Fentanyl and Hydromorphone, part of another treatment arm in this trial, work for a shorter time and need more frequent administration to maintain pain control. Both Fentanyl and Hydromorphone effectively manage post-surgery pain and are commonly used. Overall, both treatments are effective, but methadone might offer the advantage of fewer doses. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa M. Einhorn, M.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. rapm.bmj.com rapm.bmj.com/content/49/9/635

Perioperative pain management for cleft palate surgery The aim of this review was to evaluate the available evidence and to develop recommendations for optimal pain management after cleft palate surgery.

2. nature.com nature.com/research-intelligence/nri-topic-summaries/cleft-lip-and-palate-surgery-pain-management-micro-362408

Cleft Lip And Palate Surgery Pain Management The findings indicated a notable opioid-sparing effect with reduced postoperative fentanyl requirements, highlighting the importance of early intervention to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06962306

Optimizing Perioperative Analgesia to Lower Pain ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2526495/

Parent-Controlled Analgesia in Children Undergoing Cleft ... Eighty seven percent of the parents were satisfied with participating in the PrCA modality. PrCA using fentanyl with a basal infusion rate of 0.63 µg/kg/hr can ...

5. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-02907-6

Preemptive analgesic effectiveness of single dose intravenous ... We try to assess whether preoperative administration of intravenous ibuprofen can decrease opioid requirements following cleft palate repair in infants.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7858197/

Is the Use of Opioids Safe after Primary Cleft Palate Repair ... Vomiting and oxygen desaturation have been associated with the use of opioids in the studied population.

7. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01412-8

Effectiveness of analgesia with hydromorphone hydrochloride ... Findings showed that pediatric patients administered hydromorphone hydrochloride had a lower FLACC pain score, especially 6 to 24 h after ...

8. epain.org epain.org/journal/view.html?doi=10.3344/kjp.2020.33.1.81

Dexmedetomidine during suprazygomatic maxillary nerve ... Dexmedetomidine during suprazygomatic maxillary nerve block for pediatric cleft palate repair, randomized double-blind controlled study.