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OpenTrials
Completed

NCT Number: NCT04177862

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

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.

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Key information

Conditions

Pain Acute Pain Anesthesia Neurologic Manifestations Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sublingual Sufentanil

Drug

30 mcg of sublingual sufentanil

IV Fentanyl

Drug

50 mcg of IV fentanyl

Primary outcomes

  1. Recovery Room Time

    Time frame: 1 day

    The time (reported in minutes) from when the patient arrives in the PACU, right after surgery, to the time that all discharge criteria are met.

Secondary outcomes

  1. Rescue Milligram Morphine Equivalents (Opioid Use After Intervention Until Discharge)

    Time frame: 1 day

    All doses of opioid medications administered following initial dosage (sufentanil or fentanyl depending on study arm) will be converted to milligram morphine equivalents and summed for reporting.

  2. Adverse Events

    Time frame: 1 day

    Number of serious adverse events (grades 3, 4, and 5) experienced by each group

  3. Postoperative Nausea and Vomiting (PONV)

    Time frame: 1 day

    Number of participants in each arm who are treated for nausea and/or vomiting.

  4. Supplemental Oxygen

    Time frame: 1 day

    Number of participants in each arm who require supplemental oxygen therapy

  5. Overall Benefit of Analgesic Score (OBAS)

    Time frame: 1 day

    Overall Benefit of Analgesic Score (OBAS) is a 7-item multi-dimensional survey that assesses analgesia benefits. Items are scored on a scale from 0 (minimal) to 4 (maximal). Total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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