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Sufentanil Intranasal

Sponsor
Centre Hospitalier Universitaire Saint Pierre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04137198
Collaborator
(none)
170
Enrollment
1
Location
2
Arms
67.3
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized trialrandomized trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
Actual Study Start Date :
Jan 22, 2020
Anticipated Primary Completion Date :
Jul 30, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in pain score [15-20 minutes after first administration of Sufentanil]

      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)

    Secondary Outcome Measures

    1. change in pain score [60 minutes after first administration of Sufentanil]

      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)

    Other Outcome Measures

    1. number of participants with adverse effects [at 15-20 and at 60 minutes]

      subjects are questioned and examined for known adverse effects of Sufentanil

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Saint Pierre Bruxelles Belgium 1000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Saint Pierre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire Saint Pierre
    ClinicalTrials.gov Identifier:
    NCT04137198
    Other Study ID Numbers:
    • SUFIN002
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Feb 5, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Centre Hospitalier Universitaire Saint Pierre
    emergency
    pain
    analgesia
    intranasal
    sufentanil
    Additional relevant MeSH terms:
    Emergencies
    Acute Pain
    Sufentanil

    Study Results

    No Results Posted as of Feb 5, 2021