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Dsuvia for Acute Pain

Phase 4

Waitlist Available

Led By Naum Shaparin, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during stay in pacu, up until discharge from pacu

Awards & highlights

Study Summary

This trial is testing whether Dsuvia will help manage postoperative pain in ambulatory surgery patients who are taking Suboxone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during day of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during day of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and during day of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Morphine Equivalence

Secondary outcome measures

Adverse Events Post Discharge From PACU

Adverse Events in the PACU

Need for Additional Opioids Following Surgery

+2 more

Side effects data

From 2021 Phase 4 trial • 64 Patients • NCT04226495

13%

Hypotension

Acute left MCA stroke

100%

80%

60%

40%

20%

Study treatment Arm

Sufentanil Bolus

Sufentanil Infusion

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

Subjects will be receive routine standard of care.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

441 Previous Clinical Trials

582,193 Total Patients Enrolled

14 Trials studying Acute Pain

28,646 Patients Enrolled for Acute Pain

Naum Shaparin, MDPrincipal InvestigatorMontefiore Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what situations is Dsuvia typically utilized?

"Dsuvia is typically prescribed as a palliative measure, but has also shown effectiveness in providing short-term opioid analgesia during general anesthesia and intubation."

Answered by AI

Could you elaborate on the research that has been conducted involving Dsuvia?

"At the moment, 17 clinical trials are being conducted on Dsuvia. 5 of those trials have already reached Phase 3 status and involve 25 different medical facilities - primarily found in Wuhan, Hubei province."

Answered by AI

Are participants who have not yet reached their seventieth birthdays eligible to join this research trial?

"This trial is open for those aged 18 to 100. However, there are 21 additional trials available specifically aimed at younger patients and 131 studies targeting older adults."

Answered by AI

Are there any vacancies in this experiment for participants?

"According to clinicaltrials.gov, this medical trial is still open and recruiting patients. The initial posting was made on May 1st 2021 with the most recent amendment published on July 22nd 2022."

Answered by AI

Is eligibility open to include my involvement in this research?

"To qualify for the trial, individuals must be in acute pain and within the ages of 18 to 100. A total of 30 participants are needed to complete this research study."

Answered by AI

Has the U.S. Food and Drug Administration given consent for Dsuvia?

"The safety of Dsuvia is rated at 3 on the scale due to it being a Phase 4 trial, signifying its approval for medical use."

Answered by AI

What is the upper limit of individuals participating in this research?

"Indeed. According to clinicaltrials.gov, this medical trial is currently recruiting participants from one clinic; the investigation was first advertised on May 1st 2021 and its most recent update was on July 22nd 2022 with a goal of enrolling thirty people in total."

Answered by AI

Recent research and studies

British Journal of AnaesthesiaJournal

Comparative Clinical Effects of Hydromorphone and Morphine: A Meta-analysis

Felden, L., C. Walter, S. Harder, R.-D. Treede, H. Kayser, D. Drover, G. Geisslinger, and J. Lötsch. 2011. “Comparative Clinical Effects of Hydromorphone and Morphine: A Meta-analysis”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aer232.

Regional Anesthesia and Pain MedicineJournal

Sufentanil Sublingual Tablet System for the Management of Postoperative Pain Following Open Abdominal Surgery

Ringold, Forrest G., Harold S. Minkowitz, Tong Joo Gan, Keith A. Aqua, Yu-kun Chiang, Mark A. Evashenk, and Pamela P. Palmer. 2015. “Sufentanil Sublingual Tablet System for the Management of Postoperative Pain Following Open Abdominal Surgery”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1097/aap.0000000000000152.

AddictionJournal

Mortality Among Regular or Dependent Users of Heroin and Other Opioids: A Systematic Review and Meta-analysis of Cohort Studies

Degenhardt, Louisa, Chiara Bucello, Bradley Mathers, Christina Briegleb, Hammad Ali, Matt Hickman, and Jennifer McLaren. 2010. “Mortality Among Regular or Dependent Users of Heroin and Other Opioids: A Systematic Review and Meta-analysis of Cohort Studies”. Addiction. Wiley. doi:10.1111/j.1360-0443.2010.03140.x.

The Journal of Behavioral Health Services & ResearchJournal