drugset / Trial / NCT03224039

Intranasal Sufentanil Versus Intravenous Morphine for the Management of Acute Pain

NCT03224039

Phase 4 Unknown 40 enrolled The Brooklyn Hospital Center
RandomizedParallel-groupTriple-blindTreatment

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

Start
2017-01-01
Primary completion
2019-01-01
Completion
2019-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified 0.1 mg/kg Intravenous
Subject Sufentanil Other / unclassified 0.7 ug/kg Intranasal

Indications

No indication recorded.