Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
Study Details
Study Description
Brief Summary
In this case, series, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the PACU in ambulatory surgery patients taking Suboxone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment 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. |
Drug: Dsuvia
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)
|
| No Intervention: Control Subjects will be receive routine standard of care. |
Outcome Measures
Primary Outcome Measures
- 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
- 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?'
- additional opioids [PACU stay to 24 hours post hospital discharge]
Look at how many additional opioids subject needed
- time to take the first additional opioid [24 hours post hospital discharge]
How soon did subject require an 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
- 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
Eligibility Criteria
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) without the use of regional anesthesia
Exclusion Criteria:
-
• Known allergic reactions to Dsuvia and its excipients
-
Severe respiratory illness including exacerbation of asthma attack
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Significant intraoperative hemodynamic instability
-
Use of Regional anesthesia techniques
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
Investigators
- Principal Investigator: Naum Shaparin, MD, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Erratum in: Ann Intern Med. 2006 Mar 21;144(6):460.
- 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. Review.
- 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.
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- 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.
- 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.
- Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. Review.
- 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.
- 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.
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