Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06962306
Phase
PHASE4
Status
Recruiting
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Conditions

  • Children
  • Cleft Palate
  • Pain
  • Perioperative Care
  • Postoperative Care

Eligibility Criteria

Sex
ALL
Age
6 Months - 4 Years
Healthy Volunteers
Not accepted

Interventions

  • Methadone hydrochloride — DRUG
    Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
  • Fentanyl/Hydromorphone — DRUG
    Per routine care

Study Details

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.

Key Dates

Start date
Jun 4, 2025
Status verified
Apr 2026
Primary completion
Jun 4, 2027
Completion
Jul 4, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methadone
    Methadone 0.2-0.25 mg/kg actual body weight
  • Active Comparator: Fentanyl/Hydromorphone
    Fentanyl/Hydromorphone per routine care

Primary Outcome Measure

Total amount of opioids medication administered [ Time Frame: From PACU discharge through postoperative day 1 (POD1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27705
Lisa M. Einhorn, M.D.
[email protected]
919-970-2805

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Duke University Medical Center· Durham, NC

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