Comparing pain relief methods after cleft palate surgery in children
Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial
PHASE4 · Duke University · NCT06962306
This study is testing whether short-acting or long-acting pain medications work better for managing pain in young children after cleft palate surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Months to 4 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06962306 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of short-acting opioids versus long-acting opioids for managing postoperative pain in infants and young children undergoing cleft palate surgery. It is a single-center, randomized, double-blind trial where participants will be assigned to receive either methadone or short-acting opioids like fentanyl and hydromorphone. The study will monitor pain control indices and collect exploratory data for up to 30 days following surgery. The surgical and anesthesia protocols will remain unchanged, focusing solely on opioid management.
Who should consider this trial
Good fit: Ideal candidates are infants and young children aged 6 months to 4 years scheduled for primary cleft palate repair.
Not a fit: Patients with chronic kidney or liver disease or those requiring admission to the Pediatric Intensive Care Unit may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children undergoing cleft palate surgery.
How similar studies have performed: Other studies have explored opioid management in postoperative care, but this specific comparison of long-acting versus short-acting opioids in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6 months to 4 years of age * Primary cleft palate repair * Signed informed consent by parent or legal guardian Exclusion Criteria: * History of chronic kidney or liver disease * Planned admission to the Pediatric Intensive Care Unit (PICU) * Additional procedures under general anesthesia for which opioids would be prescribed * Any patient ineligible for study participation at the discretion of the investigators
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Lisa M. Einhorn, M.D. — Duke University
- Study coordinator: Lisa M. Einhorn, M.D.
- Email: lisa.einhorn@duke.edu
- Phone: 919 970 2805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cleft Palate, Pain, Postoperative Care, Perioperative Care, Children, Cleft palate surgery, Perioperative pain management, Analgesia