drugset / Trial / NCT02410707

Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults

NCT02410707

Completed 43 enrolled Albert Einstein Healthcare Network
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.

Timeline

Start
2015-02
Primary completion
2018-02
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified 50 % Inhaled
Background Oxygen Other / unclassified 50 % Inhaled
Background Propofol Small molecule 0.5 mg/kg Intravenous

Indications