Sublingual Sufentanil vs Intravenous Fentanyl for Acute Pain in the Ambulatory Surgery Center

NCT ID: NCT04177862

Last Updated: 2021-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2020-01-31

Brief Summary

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The purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of IV fentanyl in a post anesthesia care setting.

Detailed Description

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This is a level I randomized prospective outcomes study comparing two groups of patients. Upon arrival in the ambulatory surgery center (ASC) post-anesthesia care unit (PACU) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. Group 1 will receive 50 mcg of IV fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. The primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.

Conditions

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Pain Pain, Acute Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sublingual Sufentanil

Single dose of sublingual sufentanil for acute pain.

Group Type EXPERIMENTAL

Sublingual Sufentanil

Intervention Type DRUG

30 mcg of sublingual sufentanil

IV Fentanyl

single dose of IV fentanyl for acute pain.

Group Type ACTIVE_COMPARATOR

IV Fentanyl

Intervention Type DRUG

50 mcg of IV fentanyl

Interventions

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Sublingual Sufentanil

30 mcg of sublingual sufentanil

Intervention Type DRUG

IV Fentanyl

50 mcg of IV fentanyl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* undergoing outpatient ambulatory surgery
* recipient of general anesthesia
* pain score of 4 or greater in the PACU

Exclusion Criteria

* non-english speaking patients
* cancer surgeries
* patients who have allergy or intolerance to the study drugs or derivatives
* patients on chronic opioids (defined as daily opioids for 3 months or longer)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron M Berg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ANES-2019-28303

Identifier Type: -

Identifier Source: org_study_id

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