Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults
Completed · Not applicable
Conditions studied: Joint Dislocation, Perianal Abscess, Abscess
In brief
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.
Key facts
- Study ID
- NCT02410707
- Run by
- Albert Einstein Healthcare Network
- People needed
- 43
- Starts
- 2015-02-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2020-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Spontaneous respirations
- 18 years of age and older
- American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2, who will be receiving sedation for an Emergency Department procedure.
- Ability to provide informed consent.
You may not qualify if…
- Comorbidities that affect ventilation, perfusion, or metabolism
- Intubated
- Cardiopulmonary instability
- Major trauma
- Sepsis
- American Society of Anesthesiologists (ASA) class 3, 4, and 5.
- Inability to provide informed consent
- Nursing home residents
- Age less than 18 years
- Non English speaking
- Pregnant women
- Under police custody
Where it is running
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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