Clinical trial NCT04716413: Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
Official title: Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.


Eligibility criteria: Inclusion Criteria:

* Age range 18-100 years
* Currently taking Suboxone
* ASA (American Society of Anesthesiology) physical score 1-3
* Able to provide a signed informed consent
* General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia

Exclusion Criteria:

* Known allergic reactions to Dsuvia and its excipients
* Severe respiratory illness including exacerbation of asthma attack
* Significant intraoperative hemodynamic instability
* Use of Regional anesthesia techniques

Primary outcomes:
measure: Morphine Equivalence
timeFrame: During day of surgery
Secondary outcomes:
measure: Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)
timeFrame: During stay in PACU, up until discharge from PACU
measure: Need for Additional Opioids Following Surgery
timeFrame: PACU stay to 24 hours post hospital discharge
measure: Time to Take the First Additional Opioid
timeFrame: 24 hours post hospital discharge
measure: Adverse Events in the PACU
timeFrame: During PACU stay, up until discharge from PACU
measure: Adverse Events Post Discharge From PACU
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Naum Shaparin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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