Actively Recruiting

Phase 4
Age: 6Months - 4Years
All Genders
NCT06962306

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Led by Duke University · Updated on 2026-04-14

60

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Who Can Participate

Age: 6Months - 4Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 months to 4 years
  • Undergoing primary cleft palate repair
  • Signed informed consent by parent or legal guardian
Not Eligible

You will not qualify if you...

  • History of chronic kidney or liver disease
  • Planned admission to the Pediatric Intensive Care Unit (PICU)
  • Additional procedures under general anesthesia requiring opioids
  • Ineligibility for study participation as determined by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27705

Actively Recruiting

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Research Team

L

Lisa M. Einhorn, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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