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

Utah System of Higher Education (USHE)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Opiate

Pain

Treatments

Drug: sufentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT01012999

32225

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)