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Opioid Analgesic

Intranasal sufentanil for Acute Pain

Phase 4
Waitlist Available
Research Sponsored by The Brooklyn Hospital Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study period (30 minutes)
Awards & highlights

Study Summary

This study will be a single-center, randomized, controlled trial conducted in the Brooklyn Hospital Center's Emergency Department (ED) expected to last 2 years. The sample size will be 40 patients with 20 patients in each treatment arm. The data points to be collected in the study are as follows: baseline characteristics (baseline pain score, date of birth, age, gender, weight and ethnicity), NRS pain scores at 5, 10, 20, and 30 minutes, dose of study treatment administered, incidence of adverse effects, time to patient discharge following administration of study treatment, patient satisfaction of pain control based on a 10-point Likert Scale, number of patients who required rescue analgesia, and amount of rescue analgesia required. 4. Once informed consent is obtained, patients will be randomized to receive Treatment A (sufentanil 0.7 mcg/kg intranasally (IN) and normal saline 1ml IV push) OR Treatment B (Normal saline 0.6 mL IN and morphine 0.1 mg/kg IV push). It should be noted that during the study period, use of additional morphine or adjuvant analgesics outside of the designated time intervals is allowed. The decision to use adjuvant analgesics is the decision of the attending physician assigned to the patient in the Emergency Department (ED).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study period (30 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study period (30 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain score
Secondary outcome measures
Adverse events
Length of stay
Pain management
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intranasal sufentanilExperimental Treatment2 Interventions
Treatment arm to include Sufentanil 0.7 mcg/kg intranasal (IN) x 1 dose Normal saline 1ml intravenous (IV) push x 1 dose
Group II: Intravenous morphineActive Control2 Interventions
b. Treatment B: Normal saline 0.3 mL IN x 1 dose Morphine 0.1 mg/kg IV push x 1 dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sufentanil
FDA approved
Normal saline
2013
Completed Phase 4
~2090

Find a Location

Who is running the clinical trial?

The Brooklyn Hospital CenterLead Sponsor
8 Previous Clinical Trials
2,087 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby May 2025