Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

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

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.

This is a single center, randomized, double blind, parallel-group dose escalation investigation in infants and children undergoing cleft palate surgery which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as perioperative analgesics. Surgical and anesthesia care, except for opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

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