Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

Phase 4

Terminated

• Conditions: Acute Pain
• Interventions: Drug: Dsuvia

• Registration Number: NCT04716413
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-20
• Study Start: 2021-09-27
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-18
• Status Verified: 2023-06
• Results First Submitted: 2023-06-29
• Results First Submitted QC: 2023-06-29
• Last Update Submitted: 2023-06-29
• Results First Posted: 2023-07-19
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Dsuvia	Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV.

Primary Outcome Measures

Name	Time	Method
Morphine Equivalence	During day of surgery	Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).

Secondary Outcome Measures

Name	Time	Method
Adverse Events Post Discharge From PACU	24 hours	Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU
Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)	During stay in PACU, up until discharge from PACU	How much time did subject take to become considered 'fit to discharge?'
Need for Additional Opioids Following Surgery	PACU stay to 24 hours post hospital discharge	A measure of how any additional opioids subjects were administered
Time to Take the First Additional Opioid	24 hours post hospital discharge	Average time for administration of first additional opioid.
Adverse Events in the PACU	During PACU stay, up until discharge from PACU	Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States