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

Pain Clinical Trial

Official title:

Pain Control and Patient Satisfaction: a Dosing Study to Determine a Safe and Effective Dose of Intra-nasal Sufentanil to Treat Emergency Department Patients With Moderate to Severe Pain Due to Extremity Trauma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01012999
• Other study ID #: 32225
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 11, 2009
• Last updated: June 21, 2017
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: June 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opiate
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief at Thirty Minutes	Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).	30 min post dose