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

NCT01012999 | Terminated Phase 1 Results

• 1 other identifier: 32225
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

acute pain, intranasal, sufentanil,; Acute pain control with an intranasal opiate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intranasal sufentanil, pain relief

EXPERIMENTAL

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

Drug: sufentanil

Interventions

sufentanil DRUG

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

Also known as: Sufenta

Intranasal sufentanil, pain relief

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Robert Stephen, MD
• Organization: University of Utah

rlstephen@comcast.net

801-587-7653

Study Officials

• Robert Stephen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 22, 2017
• Results First Posted: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)