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NCT Number: NCT06962306

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

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.

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Key information

Conditions

Cleft Palate Agnosia Children Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Perioperative Care Postoperative Care Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Lisa M. Einhorn, M.D.

CONTACT

[email protected]

919-970-2805

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone Hydrochloride

Drug

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

Fentanyl/Hydromorphone

Drug

Per routine care

Primary outcomes

  1. Total amount of opioids medication administered

    Time frame: From PACU discharge through postoperative day 1 (POD1)

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

Secondary outcomes

  1. Total amount of opioid medications administered

    Time frame: Up to 7 days after surgery

    Total (post-PACU in-hospital and post-discharge) opioids used (number of daily doses and OME/kg)

  2. Postanesthesia Care Unit (PACU) opioid medication administration

    Time frame: Up to 6 hours after surgery

    Binary (yes/no) need for opioid administration in the PACU

  3. Area under the curve (AUC) pain trajectories

    Time frame: Through hospital discharge (up to 4 days)

    In-hospital AUC pain trajectories calculated from pain intensity scores on the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. The FLACC pain scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.

  4. Average daily pain intensity

    Time frame: Up to 7 days after surgery

    Average daily pain scores using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. The FLACC pain scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa M. Einhorn, M.D.

CONTACT

[email protected]

919 970 2805

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: OPAL-Cleft

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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