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

NCT ID: NCT01012999

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-03-31

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.

Conditions

Pain; Opiate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intranasal sufentanil, pain relief

Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period

Group Type: EXPERIMENTAL

sufentanil

Intervention Type: DRUG

Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period

Interventions

sufentanil

Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period

Intervention Type: DRUG

Other Intervention Names

Sufenta

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Robert Stephen, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Stephen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

32225

Identifier Type: -

Identifier Source: org_study_id