A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain (NCT01012999) | Clinical Trial Compass
TerminatedPhase 1/2
A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
Stopped: Difficulty enrolling patients
United States16 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)