Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess

NCT03127371 | Terminated DMC

• 1 other identifier: HN4861
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nitrous Oxide; Abscess; Incision and drainage

Outcome Measures

Primary Outcomes (1)

• Change in VAS pain score from baseline

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

  Through study completion, an average of 45 minutes

Secondary Outcomes (8)

• Nitrous oxide duration

  day 1

• Physician Satisfaction Survey

  day 1

• Patient Satisfaction Survey

  day 1

• Pulse Rate

  day 1

• Respiratory Rate

  day 1

Study Arms (2)

Nitrous Oxide

EXPERIMENTAL

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 using lidocaine local anesthesia administered subcutaneously. 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: Nitrous Oxide

Oxygen

EXPERIMENTAL

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 using lidocaine local anesthesia administered subcutaneously. The device will deliver only oxygen at a fixed concentration of 100%. The on demand valve requires patient inspiration to trigger dosing.

Drug: Oxygen

Interventions

Nitrous Oxide DRUG

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.

Also known as: Sedara Gas Mixer

Nitrous Oxide

Oxygen DRUG

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.

Also known as: O2

Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Emergency Medicine Foundation: collaborator

Study Sites (1)

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Abscess; Surgical Wound

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Officials

• Joseph P Herres, DO

  Albert Eisntein Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 25, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)