NCT06962306

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
14mo left

Started Jun 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

April 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

June 4, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 30, 2025

Last Update Submit

April 10, 2026

Conditions

Cleft PalatePainPostoperative CarePerioperative CareChildren

Keywords

Cleft palate surgeryPerioperative pain managementAnalgesiaMethadone

Outcome Measures

Primary Outcomes (1)

  • Total amount of opioids medication administered

    Post-PACU in-hospital opioid use in oral morphine milligram equivalents (OMEs) per kilogram through POD1

    From PACU discharge through postoperative day 1 (POD1)

Secondary Outcomes (4)

  • Total amount of opioid medications administered

    Up to 7 days after surgery

  • Postanesthesia Care Unit (PACU) opioid medication administration

    Up to 6 hours after surgery

  • Area under the curve (AUC) pain trajectories

    Through hospital discharge (up to 4 days)

  • Average daily pain intensity

    Up to 7 days after surgery

Study Arms (2)

Methadone

ACTIVE COMPARATOR

Methadone 0.2-0.25 mg/kg actual body weight

Drug: Methadone hydrochloride

Fentanyl/Hydromorphone

ACTIVE COMPARATOR

Fentanyl/Hydromorphone per routine care

Drug: Fentanyl/Hydromorphone

Interventions

Methadone hydrochlorideDRUG

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

Methadone
Fentanyl/HydromorphoneDRUG

Per routine care

Fentanyl/Hydromorphone

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Cleft PalatePainAgnosia

Interventions

MethadoneFentanylHydromorphone

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Lisa M. Einhorn, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M. Einhorn, M.D.

CONTACT

919 970 2805lisa.einhorn@duke.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 8, 2025

Study Start

June 4, 2025

Primary Completion (Estimated)

June 4, 2027

Study Completion (Estimated)

July 4, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified data will be shared at the discretion of the PI upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
IPD will be available 1 year after study completion.

Locations

US(1)