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

This study has been terminated.
(Difficulty enrolling patients)
Sponsor:
Information provided by (Responsible Party):
Robert Stephen, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT01012999
First received: November 11, 2009
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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
Pain
Opiate
Drug: sufentanil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Utah:

Primary Outcome Measures:
  • Significant pain relief [ Time Frame: Within 30 minutes of drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of intra-nasal sufentanil [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    Drug: sufentanil
    Intra-nasal delivery, dosing range 0.5-1.0 mcg/kg, administered once at the beginning of the 30 minute study period
    Other Name: Sufenta
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 yo 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, URI, sinusitis);
  • pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency;
  • presence of other painful injuries; systolic BP less than 100 mm Hg;
  • patient seems or is confused or has a head injury; room air oxygenation less than 95%;
  • patient has COPD, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robert Stephen, MD, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01012999     History of Changes
Other Study ID Numbers: 32225
Study First Received: November 11, 2009
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014