Trial Outcomes & Findings for A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain (NCT NCT01012999)

Results Overview

Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

30 min post dose

Results posted on

2017-06-22

Over a 2 year period we recruited 16 patients who presented to a single Emergency Department.

Participant milestones
Measure	Intranasal Sufentanil, Pain Relief Patients with a suspected acute bony injury to an extremity and in moderate to severe pain. Intranasal administration, 0.5 mcg/kg, one time dose.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Intranasal Sufentanil, Pain Relief Patients with a suspected acute bony injury to an extremity and in moderate to severe pain. Intranasal administration, 0.5 mcg/kg, one time dose.
Overall Study Protocol Violation	1

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

Baseline characteristics by cohort
Measure	Intranasal Sufentanil, Pain Relief n=16 Participants Patients with a suspected acute bony injury to an extremity and in moderate to severe pain. Intranasal administration, 0.5 mcg/kg to an extremity and in moderate to severe pain, one time dose.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

Timeframe: 30 min post dose

Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).

Outcome measures
Measure	Intranasal Sufentanil, Pain Relief n=15 Participants Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
Pain Relief at Thirty Minutes	4.3 Units on a scale Standard Deviation 2.2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Intranasal Sufentanil, Pain Relief n=16 participants at risk Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
Respiratory, thoracic and mediastinal disorders transient hypoxia	6.2% 1/16 • Number of events 1

University of Utah

Phone: 801-587-7653