Sufentanil Intranasal

The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.

Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.

Study Overview

• Status: Recruiting
• Conditions: Emergencies; Analgesia; Pain, Acute; Sufentanil
• Intervention / Treatment: Drug: Sufentanil

Detailed Description

In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.

The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.

Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bernard Kreps, MD; Phone Number: +3225353495; Email: bernard_kreps@stpierre-bru.be
• Study Contact Backup: Name: Stefano Malinverni, MD; Email: stefano_malinverni@stpierre-bru.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • Recruiting
    • CHU Saint Pierre
    • Contact: Stefano Malinverni, MD; Phone Number: +3225354051; Email: stefano_malinverni@stpierre-bru.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more

Exclusion Criteria:

• pregnant
• <18 years
• prisoners
• lesions of head, face or abdomen
• no consent given or possible
• pain not scorable
• known drug abuse or substitution therapy
• chronic level 3 pain medication
• intake of level 3 < 8 hours
• intoxicated patient
• allergy or intolerance to opiates
• renal or hepatic insufficiency
• < 50kg body weight
• hemodynamic instability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; classic analgetic protocol
Experimental: intervention; intranasal Sufentanil	Drug: Sufentanil; intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses; Other Names: Sufenta Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain score	pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)	15-20 minutes after first administration of Sufentanil

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain score	pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)	60 minutes after first administration of Sufentanil

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with adverse effects	subjects are questioned and examined for known adverse effects of Sufentanil	at 15-20 and at 60 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Anticipated): July 30, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pain; emergency; intranasal; sufentanil; analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: SUFIN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After publication all IPD will be made available through researchgate.com profile of backup investigator
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: access will be granted to any researcher requesting access through Researchgate.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No