Sufentanil Intranasal

Phase 4

Recruiting

• Conditions: Pain, Acute; Sufentanil; Analgesia; Emergencies
• Interventions: Drug: Sufentanil

• Registration Number: NCT04137198
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief 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.

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-23
• Study Start: 2020-01-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05
• Primary Completion: 2025-07-30
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Sufentanil	intranasal Sufentanil

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

CHU Saint Pierre; 🇧🇪 Bruxelles, Belgium