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Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

Primary Purpose

Acute Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dsuvia
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) 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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

Subjects will be receive routine standard of care.

Outcomes

Primary Outcome Measures

Morphine Equivalence
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

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

Full Information

First Posted
January 13, 2021
Last Updated
June 29, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04716413
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to funding, lack of participants
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will be receive routine standard of care.
Intervention Type
Drug
Intervention Name(s)
Dsuvia
Intervention Description
Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
Primary Outcome Measure Information:
Title
Morphine Equivalence
Description
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
Time Frame
During day of surgery
Secondary Outcome Measure Information:
Title
Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)
Description
How much time did subject take to become considered 'fit to discharge?'
Time Frame
During stay in PACU, up until discharge from PACU
Title
Need for Additional Opioids Following Surgery
Description
A measure of how any additional opioids subjects were administered
Time Frame
PACU stay to 24 hours post hospital discharge
Title
Time to Take the First Additional Opioid
Description
Average time for administration of first additional opioid.
Time Frame
24 hours post hospital discharge
Title
Adverse Events in the PACU
Description
Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU
Time Frame
During PACU stay, up until discharge from PACU
Title
Adverse Events Post Discharge From PACU
Description
Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naum Shaparin, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28511196
Citation
Anderson TA, Quaye ANA, Ward EN, Wilens TE, Hilliard PE, Brummett CM. To Stop or Not, That Is the Question: Acute Pain Management for the Patient on Chronic Buprenorphine. Anesthesiology. 2017 Jun;126(6):1180-1186. doi: 10.1097/ALN.0000000000001633.
Results Reference
background
PubMed Identifier
21054613
Citation
Degenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4.
Results Reference
background
PubMed Identifier
15781180
Citation
Johnson RE, Fudala PJ, Payne R. Buprenorphine: considerations for pain management. J Pain Symptom Manage. 2005 Mar;29(3):297-326. doi: 10.1016/j.jpainsymman.2004.07.005.
Results Reference
background
PubMed Identifier
16418412
Citation
Alford DP, Compton P, Samet JH. Acute pain management for patients receiving maintenance methadone or buprenorphine therapy. Ann Intern Med. 2006 Jan 17;144(2):127-34. doi: 10.7326/0003-4819-144-2-200601170-00010. Erratum In: Ann Intern Med. 2006 Mar 21;144(6):460.
Results Reference
background
PubMed Identifier
23702611
Citation
Hansen HB, Siegel CE, Case BG, Bertollo DN, DiRocco D, Galanter M. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. J Behav Health Serv Res. 2013 Jul;40(3):367-77. doi: 10.1007/s11414-013-9341-3.
Results Reference
background
PubMed Identifier
15957687
Citation
Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. doi: 10.1177/0310057X0503300104.
Results Reference
background
PubMed Identifier
378645
Citation
Heel RC, Brogden RN, Speight TM, Avery GS. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1979 Feb;17(2):81-110. doi: 10.2165/00003495-197917020-00001.
Results Reference
background
PubMed Identifier
9052292
Citation
Claxton AR, McGuire G, Chung F, Cruise C. Evaluation of morphine versus fentanyl for postoperative analgesia after ambulatory surgical procedures. Anesth Analg. 1997 Mar;84(3):509-14. doi: 10.1097/00000539-199703000-00008.
Results Reference
background
PubMed Identifier
14622770
Citation
Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
Results Reference
background
PubMed Identifier
21841049
Citation
Felden L, Walter C, Harder S, Treede RD, Kayser H, Drover D, Geisslinger G, Lotsch J. Comparative clinical effects of hydromorphone and morphine: a meta-analysis. Br J Anaesth. 2011 Sep;107(3):319-28. doi: 10.1093/bja/aer232. Epub 2011 Aug 5.
Results Reference
background
PubMed Identifier
27781372
Citation
Minkowitz HS, Leiman D, Melson T, Singla N, DiDonato KP, Palmer PP. Sufentanil Sublingual Tablet 30 mcg for the Management of Pain Following Abdominal Surgery: A Randomized, Placebo-Controlled, Phase-3 Study. Pain Pract. 2017 Sep;17(7):848-858. doi: 10.1111/papr.12531. Epub 2017 Feb 10.
Results Reference
background
PubMed Identifier
26079801
Citation
Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746.
Results Reference
background
PubMed Identifier
25318408
Citation
Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152.
Results Reference
background
Citation
W.M. Tvetenstrand CD, Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting., J Clin Anesth Pain Manag. 4 2.
Results Reference
background

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Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

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