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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137198
Other study ID # SUFIN002
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 22, 2020
Est. completion date September 1, 2025

Study information

Verified date February 2021
Source Centre Hospitalier Universitaire Saint Pierre
Contact Bernard Kreps, MD
Phone +3225353495
Email bernard_kreps@stpierre-bru.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date September 1, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium CHU Saint Pierre Bruxelles

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other number of participants with adverse effects subjects are questioned and examined for known adverse effects of Sufentanil at 15-20 and at 60 minutes
Primary 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 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
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