Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
NCT ID: NCT04716413
Last Updated: 2023-07-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
3 participants
INTERVENTIONAL
2021-09-27
2022-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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)
Control
Subjects will be receive routine standard of care.
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe respiratory illness including exacerbation of asthma attack
* Significant intraoperative hemodynamic instability
* Use of Regional anesthesia techniques
18 Years
100 Years
ALL
No
Sponsors
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Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Naum Shaparin, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-12649
Identifier Type: -
Identifier Source: org_study_id
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