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Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess

Primary Purpose

Abscess

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nitrous Oxide
Oxygen
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess focused on measuring Nitrous Oxide, Abscess, Incision and drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Einstein Medical Center Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nitrous Oxide

Oxygen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in VAS pain score from baseline
VAS measured pre-anesthesia, pre-procedure, immediately post procedure, and 10 minutes following procedure.

Secondary Outcome Measures

Nitrous oxide duration
Total number of minutes Nitrous oxide was inhaled by patients
Physician Satisfaction Survey
Physician satisfaction with use of Nitrous oxide/Oxygen in pain control
Patient Satisfaction Survey
Patient satisfaction with use of Nitrous oxide/Oxygen in pain control
Pulse Rate
beats per minute
Respiratory Rate
breaths per minute
Blood Pressure
mmHg
Continuous Oxygen Saturation
Oxygen saturation measured every 20 milliseconds captured by a monitoring device during study period
Continuous End tidal CO2
End tidal Co2 measured every 20 milliseconds captured by a monitoring device during study period

Full Information

First Posted
March 28, 2017
Last Updated
April 26, 2021
Sponsor
Albert Einstein Healthcare Network
Collaborators
Emergency Medicine Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03127371
Brief Title
Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess
Official Title
Adjunctive Nitrous Oxide to Lidocaine Anesthesia During ED Incision and Drainage of Abscess in Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment rate
Study Start Date
September 2016 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
Collaborators
Emergency Medicine Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study will be a prospective, randomized, double-blinded clinical trial of patients undergoing incision and drainage of abscesses in the ED of an urban, tertiary, academic medical center. Subjects will be randomized to one of two groups: 100% oxygen or 50/50 O2/Nitrous oxide while undergoing standard incision and drainage of cutaneous abscess. Recruitment Methods The research associates as well as the heath care team (both residents and attending physicians) will screen patients who may need incision and drainage of abscesses in the ED and may qualify for the study. Research associates will use the Cerner/AeCIS System for screening, and they will be in charge of informed consent, enrollment, placement of the capnography monitor, as well as data collection. The health care team will be in charge of the local anesthesia and incision and drainage of abscess and all other management. Procedures Involved in the Research Initial medical assessment will be made in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patient meets eligibility criteria, then they will be approached by a research associate for enrollment in the study. After informed consent is obtained and prior to starting the procedure, standard vital sign monitoring will be placed on the patient (electrocardiogram, non-invasive blood pressure monitoring, pulse oximetry, and capnography). The Capnostream 20 ETCO2 monitor will be used as the primary device to measure ETCO2, with a nasal cannula capable of delivering supplemental oxygen and measuring ETCO2 (Oridion Medical, Needham, MA). The SEDARA gas mixer system [Linde Gas North America LLC] will be used as our primary nitrous oxide delivery device. It will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. It uses a patient driven demand valve system that is hand held. This device provides a consistent, fixed 50%/50% blend of nitrous oxide (N2O) and oxygen (O2), eliminates the need to titrate, and provides fixed concentrations for controlled and consistent dosing. The device comparator detects dosing imbalance to protect against hypoxic mixtures, it cannot deliver nitrous gas without concurrent oxygen, and the device has an anti-asphyxia valve override. The on demand valve requires patient inspiration to trigger dosing and also allows option for 100% oxygen delivery through same delivery mask. This portable device scavenges exhaled waste gases for environmental safety, as well as a key mechanism that renders the system inoperable without it for security. After informed consent, the patient will fill out a pre procedure questionnaire and a 100 mm VAS baseline pain scale. The patient will be randomized to either the control group (100% oxygen) or treatment group (50/50) by using a randomization scheme generated using the web site Randomization.com (http://www.randomization.com). The treating physician will measure erythema and induration using a measuring tape, estimate the amount of fluctuance as small, moderate, or large, and note the location of the abscess. Once randomized, subjects will be given the mask for delivery of inhaled gas and instructed on its use, and the research associate will mark the time the patient began using the device. The SEDARA Gas Mixer will be only facing the research associate as to ensure blinding of study arm by provider and subject. The subject will be given nitrous oxide or oxygen for a minimum of 10 minutes prior to incision and drainage. The treating physician will then clean the abscess with chlorhexidine solution. The abscess will be incised with a single linear incision using a No. 11 surgical scalpel, and a cotton tipped applicator will be used to break up loculations within the abscess cavity. The method of I&D, and decision to probe to break-up loculations will be standardized, but the degree of probing, depth, and decision to pack will be left to the discretion of the treating physician. Subjects pain will be assessed using the VAS at ten minutes after NO administration but before beginning I&D, immediately post I&D procedure, and ten minutes after procedure completion. The subject's clinical data (refer to data management) will be entered into a standardized data collection form. Study will end when the subjects recovers back to baseline. Vital signs will be flagged electronically when a physician intervenes for clinical respiratory depression. Respiratory depression will be defined as 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. Once the procedure is complete, and the patient is deemed back to their mental status baseline, they will fill out a post procedure satisfaction questionnaire. The physician will also fill out a post procedure questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
Nitrous Oxide, Abscess, Incision and drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrous Oxide
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxygen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitrous Oxide
Other Intervention Name(s)
Sedara Gas Mixer
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
O2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in VAS pain score from baseline
Description
VAS measured pre-anesthesia, pre-procedure, immediately post procedure, and 10 minutes following procedure.
Time Frame
Through study completion, an average of 45 minutes
Secondary Outcome Measure Information:
Title
Nitrous oxide duration
Description
Total number of minutes Nitrous oxide was inhaled by patients
Time Frame
day 1
Title
Physician Satisfaction Survey
Description
Physician satisfaction with use of Nitrous oxide/Oxygen in pain control
Time Frame
day 1
Title
Patient Satisfaction Survey
Description
Patient satisfaction with use of Nitrous oxide/Oxygen in pain control
Time Frame
day 1
Title
Pulse Rate
Description
beats per minute
Time Frame
day 1
Title
Respiratory Rate
Description
breaths per minute
Time Frame
day 1
Title
Blood Pressure
Description
mmHg
Time Frame
day 1
Title
Continuous Oxygen Saturation
Description
Oxygen saturation measured every 20 milliseconds captured by a monitoring device during study period
Time Frame
Baseline until 10 minutes following procedure
Title
Continuous End tidal CO2
Description
End tidal Co2 measured every 20 milliseconds captured by a monitoring device during study period
Time Frame
Baseline until 10 minutes following procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Herres, DO
Organizational Affiliation
Albert Eisntein Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Einstein Medical Center Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess

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