Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2027-07-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Methadone vs. Fentanyl Administration on Postoperative Pain Control in Pediatric Patients Undergoing Cardiac Surgery

NCT02747875

Opioid Use, Unspecified

TERMINATED NA

Intraoperative Methadone in Children Undergoing Surgery

NCT04680286

Pain, Acute Pain, Postoperative Children, Only

TERMINATED PHASE3

Methadone in Ambulatory Surgery

NCT02300077

Post-operative Pain Anesthesia

COMPLETED NA

Methadone Pharmacokinetics in Cardiac Surgery

NCT07226245

Postoperative Pain Management

NOT_YET_RECRUITING PHASE4

Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia

NCT01430182

Pain, Postoperative

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cleft Palate Pain Postoperative Care Perioperative Care Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Methadone

Methadone 0.2-0.25 mg/kg actual body weight

Group Type ACTIVE_COMPARATOR

Methadone hydrochloride

Intervention Type DRUG

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

Fentanyl/Hydromorphone

Fentanyl/Hydromorphone per routine care

Group Type ACTIVE_COMPARATOR

Fentanyl/Hydromorphone

Intervention Type DRUG

Per routine care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methadone hydrochloride

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

Intervention Type DRUG

Fentanyl/Hydromorphone

Per routine care

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No