Cleft Palate, Pain, Postoperative Care, Perioperative Care, Children
Conditions
Keywords
Cleft palate surgery, Perioperative pain management, Analgesia, Methadone
Brief 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.
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
Initial dosing 0.2mg/kg, potential to escalate to 0.25mg/kg following interim analysis
Per routine care
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of opioids medication administered | From PACU discharge through postoperative day 1 (POD1) | Post-PACU in-hospital opioid use in oral morphine milligram equivalents (OMEs) per kilogram through POD1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of opioid medications administered | Up to 7 days after surgery | Total (post-PACU in-hospital and post-discharge) opioids used (number of daily doses and OME/kg) |
| Postanesthesia Care Unit (PACU) opioid medication administration | Up to 6 hours after surgery | Binary (yes/no) need for opioid administration in the PACU |
| Area under the curve (AUC) pain trajectories | Through hospital discharge (up to 4 days) | 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. |
| Average daily pain intensity | Up to 7 days after surgery | 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. |
Countries
United States
Contacts
Primary ContactLisa M. Einhorn, M.D.
Outcome results
None listed