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NCT03127371 · ClinicalTrials.gov registry record · NA
Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess
A NA study, sponsored by Albert Einstein Healthcare Network.
- Terminated
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT03127371 is a NA study that was terminated before completion, run by Albert Einstein Healthcare Network. The registered enrollment target is 41 participants.
The verdict
NCT03127371, a NA study, was terminated before completion, sponsored by Albert Einstein Healthcare Network.
- TERMINATED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study aims to describe the safety and efficacy of adjunctive nitrous oxide to lidocaine anesthesia in decreasing pain in adults during incision and drainage (I\&D) of cutaneous abscesses in the emergency department (ED). Incision and drainage has been considered one of the more painful procedures performed in the ED. Standard care recommends a minimum of local anesthesia, however, there is no consensus on the appropriateness of pain management during ED painful procedures, such as incision and drainage. Oligoanalgesia continues to be a problem for ED health care providers. Despite extensive research in mechanisms of pain, factors relating to inadequate pain management, and evidence-based pain management strategies, implementation of effective pain management in the ED is still lacking. Nitrous oxide is a weak sedative agent with analgesic and anxiolytic properties. Rapid onset and short duration of action, ease of use, and favorable cardio-respiratory profile makes it an ideal agent for analgesia in the ED and may provide a novel strategy for pain management in I\&D. While it has been studied an adjunct to laceration repair in children and labor in women, the use in the ED setting is not known. Adult patients capable of consenting, with simple cutaneous abscess requiring incision and drainage are the targeted population. Eligible patients who consent to the study will be randomized to one of two groups: nitrous oxide/local anesthesia or oxygen/local anesthesia. Primary endpoints assessed will be pain scores using the VAS at baseline, ten minutes after NO administration, immediately post I\&D procedure, and ten minutes after procedure completion. Additionally, secondary endpoints of patient and physician procedure satisfaction scores, total time of nitrous oxide used, and presence of adverse events, including respiratory depression defined by peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, the loss of the ETCO2
Interventions
- DRUG Oxygen
- DRUG Nitrous Oxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2016-09 |
| Est. Completion | 2021-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03127371
The ClinicalTrials.gov registry entry for NCT03127371 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein Healthcare Network, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.
NCT03127371 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03127371 about?
NCT03127371 is a clinical study titled "Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess". This study aims to describe the safety and efficacy of adjunctive nitrous oxide to lidocaine anesthesia in decreasing pain in adults during incision and drainage (I\&D) of cutaneous abscesses in the emergency department (ED). Incision and drainage has been considered one of the more painful procedur...
What is the current status of trial NCT03127371?
This trial is currently terminated. It is a NA study. The enrollment target is 41 participants. The study started on 2016-09. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT03127371?
The interventions under investigation include: Oxygen (DRUG), Nitrous Oxide (DRUG).
Who is sponsoring clinical trial NCT03127371?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
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