Chronic Pain Clinical Trial
Official title:
A Pilot, Randomized, Double-blind, Placebo-controlled Single-center Study to Evaluate the Safety and Efficacy of SUBSYS™ (Fentanyl Sublingual Spray) for the Treatment of Acute Procedure-related Pain in a Monitored Setting
Participants will be selected from patients who have been scheduled at the site for treatment
of chronic pain without sedation. They will receive either fentanyl sublingual spray or a
matching placebo sublingual spray that delivers no medication.
Participants may take pain killers at any time after the procedure for pain relief. They will
be given a diary card, which they will take home. They will record the name of the medication
taken, the time, and dosage.
The study coordinator will call participants about 24 hours after the procedure to collect
information from the diary card and follow up information about pain and side effects
(adverse events) after they left the site.
Participants will be separated into opioid-experienced and opioid-naïve groups. Participants in each group will be randomly allocated in a 3:1 ratio to receive fentanyl sublingual spray (FSS) or a matching placebo sublingual spray (PSS) 10 minutes before the scheduled procedure. Based on FDA guidelines, opioid-experienced FSS participants will receive FSS 400 µg, and opioid-naïve FSS participants will be further randomized in a 1:1 ratio to receive either 100 µg or 200 µg. All participants randomized to placebo receive the same matching PSS, regardless of opioid experience. Pain and sedation will be recorded multiple times during the scheduled procedure. If rescue medication is needed during the procedure, local anesthetic standard of care for the procedure will be administered and recorded in the study record. Efficacy and safety/tolerability of fentanyl sublingual spray will be evaluated among and between the treatment groups. ;
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