A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
- Registration Number
- NCT01012999
- Lead Sponsor
- University of Utah
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intranasal sufentanil, pain relief sufentanil Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period
- Primary Outcome Measures
Name Time Method Pain Relief at Thirty Minutes 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States