Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methadone hydrochloride, Fentanyl/Hydromorphone.
- Who it may be relevant to
- Registry conditions: Cleft Palate, Pain, Postoperative Care, Perioperative Care. Basic parameters: 6 months — 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial
Overview
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.
Detailed 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.
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
Primary outcome measures
- Total amount of opioids medication administered [Time frame: From PACU discharge through postoperative day 1 (POD1)]
Secondary outcome measures (4)
- Total amount of opioid medications administered [Time frame: Up to 7 days after surgery]
- Postanesthesia Care Unit (PACU) opioid medication administration [Time frame: Up to 6 hours after surgery]
- Area under the curve (AUC) pain trajectories [Time frame: Through hospital discharge (up to 4 days)]
- Average daily pain intensity [Time frame: Up to 7 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT06962306 · Pro00117598