Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess

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 waveform for more than 15 seconds. The vital signs, medical conditions, demographics, and abscess dimensions will also be collected.

Conditions

• Abscess

Interventions

DRUG

Nitrous Oxide

Patients undergoing incision and drainage of abscess will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device while undergoing standard incision and drainage of cutaneous abscess . The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.

DRUG

Oxygen

Patients undergoing incision and drainage of abscess will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive 100% oxygen gas via the Nitrous Oxide gas mixer device while undergoing standard incision and drainage of cutaneous abscess . The device will deliver only oxygen at a fixed concentration of 100%. The on demand valve requires patient inspiration to trigger dosing.

Sponsors & Collaborators

• Emergency Medicine Foundation

  collaborator OTHER

• Albert Einstein Healthcare Network

  lead OTHER

Principal Investigators

• Joseph P Herres, DO · Albert Eisntein Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2021-04-01

Completion

2021-04-01

Countries

• United States

Study Locations