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 tonsillectomy surgery.
This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Per routine care
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis
Duke University School of Medicine
Durham, North Carolina, United States
Total Amount of Opioid Medications Administered
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
Time frame: Up to 7 days post surgery
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain
The PPPM has 15 yes/no questions which results in a score from 0-15, where a higher score indicates greater pain. A score of at least 6 out of 15 signifies clinically significant pain. The percentage of scores \> or = 6 is shown below.
Time frame: Up to 7 days post surgery
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale
Patient caregiver (as proxy) pain scores over past 7 days. Scale of 1 to 6, where 1=had no pain and 6=almost always had pain.
Time frame: Up to 7 days post surgery
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale
Numeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Time frame: Up to 7 days post surgery
Doses of Prescription Opioid Used Following Hospital Discharge
Number of doses of prescription medication used.
Time frame: Up to 7 days post surgery
Opioid Administration in the PACU (Post-anesthesia Care Unit)
Opioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.
Time frame: Up to 6 hours post surgery
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