Sufentanil Intranasal

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Enrolling; Phase 4

Conditions: Sufentanil; Emergencies; Pain, Acute; Analgesia

Treatments: Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT04137198

SUFIN002

Details and patient eligibility

About

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

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

control

No Intervention group

Description:

classic analgetic protocol

intervention

Experimental group

Description:

intranasal Sufentanil

Treatment:

Drug: Sufentanil