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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

Interventions

  • Drug: sufentanil
    • Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period

Arms, Groups and Cohorts

  • Experimental: Intranasal sufentanil, pain relief
    • Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert Stephen, MD, Associate Professor – University of Utah
  • Overall Official(s)
    • Robert Stephen, MD, Principal Investigator, University of Utah

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