NCT04137198

Sufentanil Intranasal

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Emergencies
• Pain, Acute
• Analgesia
• Sufentanil

Interventions

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

Timeline

• Start date: 2020-01-22
• Primary completion: 2025-07-30
• Completion: 2025-09-01
• First posted: 2019-10-23
• Last updated: 2021-02-05

Locations

1 site across 1 country: Belgium