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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01012999
Recruitment Status : Terminated (Difficulty enrolling patients)
First Posted : November 13, 2009
Results First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain Opiate Drug: sufentanil Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Study Start Date : November 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012999


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

Responsible Party: Robert Stephen, MD, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01012999     History of Changes
Other Study ID Numbers: 32225
First Posted: November 13, 2009    Key Record Dates
Results First Posted: June 22, 2017
Last Update Posted: June 22, 2017
Last Verified: June 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:
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics