Opiate, Pain
Conditions
Keywords
acute pain, intranasal, sufentanil,, Acute pain control with an intranasal opiate
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.
Interventions
DRUGsufentanil
Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief at Thirty Minutes | 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). |
Countries
United States
Participant flow
Recruitment details
Over a 2 year period we recruited 16 patients who presented to a single Emergency Department.
Participants by arm
| Arm | Count |
|---|---|
| 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 to an extremity and in moderate to severe pain, one time dose. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Intranasal Sufentanil, Pain Relief |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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).
Time frame: 30 min post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Sufentanil, Pain Relief | Pain Relief at Thirty Minutes | 4.3 Units on a scale | Standard Deviation 2.2 |