N/A
N=43
Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults
Joint Dislocation · Perianal Abscess · Abscess
Bottom Line
View on ClinicalTrials.gov: NCT02410707 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Total Number of Respiratory Depression Events — 0 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nitrous Oxide arm (Drug); Propofol (Drug); Oxygen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein Healthcare Network
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Respiratory Depression Events |
— | — |
| SECONDARY Total Number of Airway Repositioning Events |
— | — |
| SECONDARY Total Number of Events Requiring Additional Oxygen |
— | — |
| SECONDARY Total Number of Positive Pressure Ventilation Events |
— | — |
| SECONDARY Total Number of Endotracheal Intubation Events |
— | — |
| SECONDARY Total Number of Physical Stimulation Events |
2 | — |
| SECONDARY Patient, Physician, and Nurse Satisfaction Surveys |
90; 95; 82; 95; 95; 86 | — |
| SECONDARY Post-Procedure VAS Pain Score |
37.33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02410707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.