A Phase 4 interventional study of Methadone hydrochloride and Fentanyl/Hydromorphone in Cleft Palate, Pain and Postoperative Care, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 6 Months to 4 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Duke University · Phase 4, Interventional, and Treatment
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.
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.
131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 85 interventional studies indexed under Cleft Palate.
Browse Cleft Palate studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Methadone 0.2-0.25 mg/kg actual body weight
Drug: Methadone hydrochloride
Fentanyl/Hydromorphone per routine care
Drug: Fentanyl/Hydromorphone
Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
Per routine care
Total amount of opioids medication administered
Post-PACU in-hospital opioid use in oral morphine milligram equivalents (OMEs) per kilogram through POD1
Time frame: From PACU discharge through postoperative day 1 (POD1)
Total amount of opioid medications administered
Total (post-PACU in-hospital and post-discharge) opioids used (number of daily doses and OME/kg)
Time frame: Up to 7 days after surgery
Postanesthesia Care Unit (PACU) opioid medication administration
Binary (yes/no) need for opioid administration in the PACU
Time frame: Up to 6 hours after surgery
Area under the curve (AUC) pain trajectories
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.
Time frame: Through hospital discharge (up to 4 days)
Average daily pain intensity
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.
Time frame: Up to 7 days after surgery
Plan to share: Yes — De-identified data will be shared at the discretion of the PI upon reasonable request.
Supporting information: Study protocol, Sap, Analytic code
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