Sufentanil Intranasal

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

Detailed Description
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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.

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

Conditions
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Emergencies, Pain, Acute, Analgesia, Sufentanil

Intervention / Treatment
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* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>classic analgetic protocol | |
| Experimental: intervention<br>intranasal Sufentanil | Drug: Sufentanil<br>* intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses<br>* Other names: Sufenta Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency, pain, analgesia, intranasal, sufentanil