Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess

• Status: Terminated
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Collaborator: Emergency Medicine Foundation
• Treatments: Nitrous Oxide

Criteria

Inclusion Criteria:

• All patients 18 years of age or older with cutaneous abscesses located on the trunk or extremities that required I&D were approached and offered participation in the study. Need for I&D was left to discretion of treating physician.

Exclusion Criteria:

• Abscesses larger than 5 cm in any dimension

• Abscesses located on the face, neck, scalp, hands, feet, perianal, rectal, or genital areas.

• Subjects with underlying conditions that could affect ventilation, perfusion, or metabolism including intubated subjects, history of COPD, subjects with clinical signs of cardiopulmonary instability, major trauma, shock, sepsis, ASA class 3, 4, and 5.

• Those unable to provide informed consent, nursing home residents, age less than 18 years, non-English speaking, pregnant women, subjects under police custody, or physician discretion.