The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.
This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period. Eligible subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo. Subjects will reside at the clinical study unit for up to a total of 7 days. The surgical procedure, the intraoperative anesthesia, and the medication used for infiltration of the wound for local anesthesia before the last stitch will be standardized. During the postoperative period in the clinical study unit, recovery procedures will be standardized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
164
Arizona Research Center
Phoenix, Arizona, United States
RECRUITINGHD Research
Bellaire, Texas, United States
RECRUITINGEndeavor Clinical Trials
San Antonio, Texas, United States
RECRUITINGTime-interval weighted summed pain intensity (SPI) with activity
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, with activity (ie, splinted cough with pillow).
Time frame: 4 to 96 hours following surgery
Time-interval weighted summed pain intensity (SPI) (rest and activity)
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at rest and with activity over various time intervals
Time frame: 4 to 96 hours following surgery
Rescue Medication
The proportion of subjects using rescue analgesic medication
Time frame: 4 to 96 hours following surgery
Rescue Medication time
The time to first use of rescue analgesic medication
Time frame: 4 to 96 hours following surgery
Rescue Medication units
Total dose of rescue analgesic medication (in morphine-equivalent units)
Time frame: 4 to 96 hours following surgery
Integrated Pain score and Rescue Medication
Integrated assessments of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at the time Rescue Medication was administered.
Time frame: 4 to 96 hours following surgery
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JBR Clinical Research
Salt Lake City, Utah, United States
RECRUITING