Sufentanil Intranasal

NCT04137198 | Unknown Phase 4

• 1 other identifier: SUFIN002
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Emergencies; Pain, Acute; Analgesia; Sufentanil

Keywords

emergency; pain; analgesia; intranasal; sufentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in pain score

  60 minutes after first administration of Sufentanil

Other Outcomes (1)

• number of participants with adverse effects

  at 15-20 and at 60 minutes

Study Arms (2)

control

NO INTERVENTION

classic analgetic protocol

intervention

EXPERIMENTAL

intranasal Sufentanil

Drug: Sufentanil

Interventions

Sufentanil DRUG

intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses

Also known as: Sufenta Forte

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint Pierre

Brussels, 1000, Belgium

RECRUITING

Related Publications (1)

• Malinverni S, Kreps B, Lucaccioni T, Bouazza FZ, Bartiaux M, Plumacker A, Pascu A, Youatou Towo P. Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial. Emerg Med J. 2024 Jan 22;41(2):83-88. doi: 10.1136/emermed-2023-213353.

  PMID: 37770120 DERIVED

MeSH Terms

Conditions

Emergencies; Acute Pain; Agnosia; Pain

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bernard Kreps, MD

CONTACT

+3225353495; bernard_kreps@stpierre-bru.be

Stefano Malinverni, MD

CONTACT

stefano_malinverni@stpierre-bru.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized trial

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 23, 2019
• Study Start: January 22, 2020
• Primary Completion: July 30, 2025
• Study Completion: September 1, 2025
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: access will be granted to any researcher requesting access through Researchgate.com

Locations

BE (1)