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

This study has been terminated.
(Difficulty enrolling patients)
Information provided by (Responsible Party):
Robert Stephen, MD, University of Utah Identifier:
First received: November 11, 2009
Last updated: June 21, 2017
Last verified: June 2017
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.

Condition Intervention Phase
Pain Opiate Drug: sufentanil Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Robert Stephen, MD, University of Utah:

Primary Outcome 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).

Enrollment: 16
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: sufentanil
Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period
Other Name: Sufenta


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01012999

United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Principal Investigator: Robert Stephen, MD University of Utah
  More Information

Responsible Party: Robert Stephen, MD, Associate Professor, University of Utah Identifier: NCT01012999     History of Changes
Other Study ID Numbers: 32225
Study First Received: November 11, 2009
Results First Received: July 4, 2013
Last Updated: June 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robert Stephen, MD, University of Utah:
acute pain, intranasal, sufentanil,
Acute pain control with an intranasal opiate

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on September 21, 2017