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Effectiveness of Nitrous Oxide in the ED

Primary Purpose

Lacerations, Abscess

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nitrous Oxide
Oxygen
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacerations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with:

  • A laceration or an abscess requiring primary repair or incision and drainage respectively, per the treating provider

Exclusion Criteria:

  • Age < 18 years
  • First trimester pregnancy
  • Inability to obtain written informed consent from subject or surrogate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Nitrous Oxide

    Placebo (Oxygen)

    Arm Description

    Patients receive nitrous oxide via mask.

    Patients receive oxygen via mask.

    Outcomes

    Primary Outcome Measures

    Visual Analog Pain Assessment Scale (0-10)
    Pain score will be collected after drug administration

    Secondary Outcome Measures

    Provider satisfaction score
    Provider satisfaction collected via survey post drug administration
    Patient satisfaction
    Patient satisfaction collected via survey post drug administration

    Full Information

    First Posted
    February 24, 2016
    Last Updated
    July 8, 2016
    Sponsor
    Christiana Care Health Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02703233
    Brief Title
    Effectiveness of Nitrous Oxide in the ED
    Official Title
    A Randomized Control Trial of Nitrous Oxide Use in the Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Feasibility
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Christiana Care Health Services

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This will be a randomized control trial. All patients for whom an emergency provider determines that abscess drainage or laceration repair are necessary will be considered for enrollment. The provider must be willing to participate in the study and be certified to use Nitrous oxide. The investigators providers completed a training course to be certified to use Nitrous oxide. The patient must be age 18 or greater, consent to participate in the study, and be able to complete a satisfaction survey. If the patient states there is a possibility of pregnancy, the investigators will regress to our standard of care and perform a urine pregnancy test. Patients with a first trimester pregnancy will be excluded. Patients who agree to enroll in the study will be randomized to Nitrous oxide versus oxygen (to be administered through the same system), and will complete a survey after the procedure, as will the provider. There will be a separate block randomization for each procedure. Providers may select other agents of choice for analgesia/sedation, such as local anesthesia, and pain medications, based on their clinical judgment. If the patient appears to have inadequate analgesia during the procedure, the provider can elect to treat as is typically done (pain medications or local anesthetics) at their discretion. The survey will ask patients to give a self-reported pain score before and during their procedure (both to be completed after the procedure). It will also ask the patient/guardian and provider for a satisfaction level with the analgesia during the procedure. In addition, side effects and procedure start and stop time will also be documented. In addition to the survey, the investigators will document clinical characteristics including diagnosis, size of laceration or abscess, additional medications required and dosages, comorbidities, age, and gender. Other data that will be gathered will include which adjunctive analgesics/anesthetics were used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lacerations, Abscess

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nitrous Oxide
    Arm Type
    Active Comparator
    Arm Description
    Patients receive nitrous oxide via mask.
    Arm Title
    Placebo (Oxygen)
    Arm Type
    Placebo Comparator
    Arm Description
    Patients receive oxygen via mask.
    Intervention Type
    Drug
    Intervention Name(s)
    Nitrous Oxide
    Intervention Type
    Other
    Intervention Name(s)
    Oxygen
    Primary Outcome Measure Information:
    Title
    Visual Analog Pain Assessment Scale (0-10)
    Description
    Pain score will be collected after drug administration
    Time Frame
    0-20 minutes after drug administration
    Secondary Outcome Measure Information:
    Title
    Provider satisfaction score
    Description
    Provider satisfaction collected via survey post drug administration
    Time Frame
    0-20 minutes after drug administration
    Title
    Patient satisfaction
    Description
    Patient satisfaction collected via survey post drug administration
    Time Frame
    0-20 minutes after drug administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with: A laceration or an abscess requiring primary repair or incision and drainage respectively, per the treating provider Exclusion Criteria: Age < 18 years First trimester pregnancy Inability to obtain written informed consent from subject or surrogate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Levine, MD
    Organizational Affiliation
    Christiana Care Health Services
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of Nitrous Oxide in the ED

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