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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: Clinical Trial NA study, sponsored by Albert Einstein Healthcare Network.

NCT03127371 is a NA study that was terminated before completion, run by Albert Einstein Healthcare Network. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

VAS measured pre-anesthesia, pre-procedure, immediately post procedure, and 10 minutes following procedure.

Interventions

  • DRUG Oxygen
  • DRUG Nitrous Oxide

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2016-09
Est. Completion 2021-04-01
Phase NA
Albert Einstein Healthcare Network

48 total trials

Why NCT03127371 stopped before completion

NCT03127371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.

NCT03127371 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03127371's enrollment target sits among peer trials

41 1446th of 2000 higher than 554 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03127371, the US trial registry maintained by the National Library of Medicine. NCT03127371 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.