A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
Stopped early · Phase 1/Phase 2
Conditions studied: Pain, Opiate
In brief
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.
Key facts
- Study ID
- NCT01012999
- Run by
- University of Utah
- People needed
- 16
- Starts
- 2009-11-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2017-06-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- University of Utah Health Sciences Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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