Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery (OPAL-Cleft)

Duke University

Status and phase: Begins enrollment this month; Phase 4

Conditions: Cleft Palate; Perioperative Care; Postoperative Care; Children; Pain

Treatments: Drug: Fentanyl/Hydromorphone; Drug: Methadone hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06962306

Pro00117598

Details and patient eligibility

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 months to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Methadone

Active Comparator group

Description:

Methadone 0.2-0.25 mg/kg actual body weight

Treatment:

Drug: Methadone hydrochloride

Fentanyl/Hydromorphone

Active Comparator group

Description:

Fentanyl/Hydromorphone per routine care

Treatment:

Drug: Fentanyl/Hydromorphone