RECRUITING

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial

Quick Facts

Study Start:2025-06-15
Study Completion:2026-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06962306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age 6 months to 4 years of age
  2. * Primary cleft palate repair
  3. * Signed informed consent by parent or legal guardian
  1. * History of chronic kidney or liver disease
  2. * Planned admission to the Pediatric Intensive Care Unit (PICU)
  3. * Additional procedures under general anesthesia for which opioids would be prescribed
  4. * Any patient ineligible for study participation at the discretion of the investigators

Contacts and Locations

Study Contact

Lisa M. Einhorn, M.D.
CONTACT
919 970 2805
lisa.einhorn@duke.edu

Principal Investigator

Lisa M. Einhorn, M.D.
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Lisa M. Einhorn, M.D., PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-15
Study Completion Date2026-06-15

Study Record Updates

Study Start Date2025-06-15
Study Completion Date2026-06-15

Terms related to this study

Keywords Provided by Researchers

  • Cleft palate surgery
  • Perioperative pain management
  • Analgesia
  • Methadone

Additional Relevant MeSH Terms

  • Cleft Palate
  • Pain
  • Postoperative Care
  • Perioperative Care
  • Children