Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

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.

Conditions

Cleft Palate, Pain, Postoperative Care, Perioperative Care, Children

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Study Overview

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Study Details

Study overview

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.

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

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Condition
Cleft Palate
Intervention / Treatment

-

Contacts and Locations

Durham

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 6 months to 4 years of age
  • * Primary cleft palate repair
  • * Signed informed consent by parent or legal guardian
  • * 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

Ages Eligible for Study

6 Months to 4 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

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

Study Record Dates

2026-06-15