Comparing pain relief methods after cleft palate surgery in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.