A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.

Official Title
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Pain Control and Patient Satisfaction: a Dosing Study to Determine a Safe and Effective Dose of Intra-nasal Sufentanil to Treat Emergency Department Patients With Moderate to Severe Pain Due to Extremity Trauma

Conditions
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Pain, Opiate

Intervention / Treatment
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* Drug: sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older; isolated traumatic injury to upper or lower extremity; alert and oriented to name, date, place; patient has a numeric pain score of 5 or higher; speaks English as their primary language; female patients are on birth control, menopausal, or are sterile (hysterectomy, tubal ligation) Exclusion Criteria: injury isolated to a finger or toe; previous nasal or sinus surgery; chronic nasal problem; acute nasal problem (ie epistaxis, upper respiratory infection, sinusitis); pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency; presence of other painful injuries; systolic Blood Pressure less than 100 mm Hg; patient seems or is confused or has a head injury; room air oxygenation less than 95%; patient has chronic obstructive pulmonary disease, severe asthma, oxygen-dependent pulmonary disease; impaired hepatic or renal function (obtained clinically or by history); weight more than 230 lbs (100 kg); alcohol or drug intoxication (per patient admission or clinical assessment of physician); elderly (> 70 years)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal sufentanil, pain relief<br>Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period | Drug: sufentanil<br>* Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period<br>* Other names: Sufenta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief at Thirty Minutes | Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all). | 30 min post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, intranasal, sufentanil,, Acute pain control with an intranasal opiate