Sufentanil Intranasal

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137198
• Other study ID #: SUFIN002
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Emergencies
• Pain, Acute
• Sufentanil

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