A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
Information source: University of Utah
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Opiate
Intervention: sufentanil (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Robert Stephen, MD, Principal Investigator, Affiliation: University of Utah
Overall contact:
Robert Stephen, MD, Phone: 801 581-2730, Email: rlstephen@comcast.net
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.
Clinical Details
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 design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Significant pain relief
Secondary outcome: Safety of intra-nasal sufentanil
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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)
Locations and Contacts
Robert Stephen, MD, Phone: 801 581-2730, Email: rlstephen@comcast.net
University of Utah Health Sciences Center, Salt Lake City, Utah 84132, United States; Recruiting
Robert Stephen, Phone: 801-581-2730, Email: rlstephen@comcast.net
Troy Madsen, MD, Phone: 801 582-7660
Robert Stephen, MD, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: November 12, 2009
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