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

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)