Difficulty enrolling patients

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.

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)

Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.

Intranasal administration, 0.5-0.9 mcg/kg, maximum dosage of 100 mcg

A single episode of transient, mild hypoxia that resolved with 2 L nasal canula oxygen and that completely resolved after 20 minutes and no longer required oxygen