Recruiting

Fentanyl vs. Methadone

Sponsor:

Duke University

Code:

NCT06962306

Conditions

Cleft Palate

Pain

Postoperative Care

Perioperative Care

Children

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

Interventions

Methadone hydrochloride

Fentanyl/Hydromorphone

Study Details

Brief summary:

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

Study ID

NCT06962306

Start date

Jun 4, 2025

Status verified date

Apr, 2026

Completion date

Jul 4, 2027

Anticipated

Primary completion date

Jun 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 4

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Methadone

Methadone 0.2-0.25 mg/kg actual body weight

active comparator: Fentanyl/Hydromorphone

Fentanyl/Hydromorphone per routine care

Interventions

Methadone hydrochloride

Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis

Fentanyl/Hydromorphone

Per routine care

Primary outcome measure

  • Total amount of opioids medication administered [ Time Frame: From PACU discharge through postoperative day 1 (POD1) ]

Central Contacts and Locations

Central contacts

Lisa M. Einhorn, M.D.

919 970 2805lisa.einhorn@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Lisa M. Einhorn, M.D.

919-970-2805lisa.einhorn@duke.edu

More Information

Sponsor

Duke University

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-14.