Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

Montefiore Medicine Academic Health System

Status and phase: Terminated; Phase 4

Conditions: Acute Pain

Treatments: Drug: Dsuvia

Study type: Interventional

Funder types: Other

Identifiers

NCT04716413

2021-12649

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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) 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Treatment

Experimental group

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.

Treatment:

Drug: Dsuvia

Control

No Intervention group

Description:

Subjects will be receive routine standard of care.