Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults, a Pilot Study

NCT02410707 NA COMPLETED Results posted

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.

Details

Lead sponsor	Albert Einstein Healthcare Network
Phase	NA
Status	COMPLETED
Enrolment	43
Start date	2015-02
Completion	2018-02

Conditions

• Joint Dislocation
• Perianal Abscess
• Abscess

Interventions

• Nitrous Oxide arm
• Propofol
• Oxygen

Primary outcomes

• Total Number of Respiratory Depression Events — day 1
  End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds

Countries

United States