Cleft PalatePhase 4OPAL-CleftNCT06962306
Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
A Phase 4 study testing Methadone hydrochloride and Fentanyl/Hydromorphone in people with Cleft Palate and Pain, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Cleft Palate, Pain, Postoperative Care
- What is being tested?
- Methadone hydrochloride and Fentanyl/Hydromorphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to 4 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 months to 4 years of age
- Primary cleft palate repair
- Signed informed consent by parent or legal guardian
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Lisa M. Einhorn, M.D., 919-970-2805, lisa.einhorn@duke.edu
About this study
Official title: Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cleft Palate, Pain, Postoperative Care, Perioperative Care, Children
- Being tested
- Methadone hydrochloride, Fentanyl/Hydromorphone
- Keywords
- Cleft palate surgery, Perioperative pain management, Analgesia, Methadone
- Medical subject headings
- Cleft Palate, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone hydrochlorideDrug
Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
Fentanyl/HydromorphoneDrug
Per routine care
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Active comparator | Methadone 0.2-0.25 mg/kg actual body weight Receives: Drug: Methadone hydrochloride |
| Fentanyl/Hydromorphone | Active comparator | Fentanyl/Hydromorphone per routine care Receives: Drug: Fentanyl/Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of opioids medication administered
Post-PACU in-hospital opioid use in oral morphine milligram equivalents (OMEs) per kilogram through POD1
Measured: From PACU discharge through postoperative day 1 (POD1)
Secondary outcomes (4)
Total amount of opioid medications administered
Total (post-PACU in-hospital and post-discharge) opioids used (number of daily doses and OME/kg)
Measured: Up to 7 days after surgery
Postanesthesia Care Unit (PACU) opioid medication administration
Binary (yes/no) need for opioid administration in the PACU
Measured: 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.
Measured: 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.
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start4 Jun 2025
- Primary completion4 Jun 2027 (estimated)
- Study completion4 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa M. Einhorn, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962306
- Sponsor's protocol ID
- Pro00117598
- Acronym
- OPAL-Cleft
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared at the discretion of the PI upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06962306
- Acronym / sponsor ID
- OPAL-Cleft / Pro00117598
- Conditions
- Cleft Palate, Pain, Postoperative Care, Perioperative Care, Children
- Keywords
- Cleft palate surgery, Perioperative pain management, Analgesia, Methadone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 4 Jun 2027 (estimated)
- Study completion
- 4 Jul 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Active comparator | Drug: Methadone hydrochlorideMethadone 0.2-0.25 mg/kg actual body weight |
| Fentanyl/Hydromorphone | Active comparator | Drug: Fentanyl/HydromorphoneFentanyl/Hydromorphone per routine care |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6 months to 4 years of age
- Primary cleft palate repair
- Signed informed consent by parent or legal guardian
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone hydrochlorideInitial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis | Drug | Methadone |
| Fentanyl/HydromorphonePer routine care | Drug | Fentanyl/Hydromorphone |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared at the discretion of the PI upon reasonable request.
Related trials for Cleft Palate
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Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
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Furlow With Buccinator and Fistula Formation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa M. Einhorn, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone hydrochloride and Fentanyl/Hydromorphone in people with Cleft Palate and Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M. Einhorn, M.D. (919 970 2805, lisa.einhorn@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of opioids medication administered (time frame: From PACU discharge through postoperative day 1 (POD1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.