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Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

NCT06962306 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DRUG

Methadone hydrochloride

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

DRUG

Fentanyl/Hydromorphone

Per routine care

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-04
Primary Completion
2027-06-04
Completion
2027-07-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962306 on ClinicalTrials.gov