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Withdrawn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
About this trial
This is an interventional treatment trial for Lacerations
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
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
NCT ID
NCT02703233
First Posted
February 24, 2016
Last Updated
July 8, 2016
Sponsor
Christiana Care Health Services
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Withdrawn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
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Effectiveness of Nitrous Oxide in the ED
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