Effectiveness of Nitrous Oxide in the ED

Abscess Clinical Trial

Official title:

A Randomized Control Trial of Nitrous Oxide Use in the Emergency Department

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02703233
• Other study ID #: 602966
• Status: Withdrawn
• Phase: Phase 4
• First received: February 24, 2016
• Last updated: July 8, 2016
• Start date: March 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2016
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Lacerations

Intervention

Drug:
• Nitrous Oxide

Other:
• Oxygen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Assessment Scale (0-10)	Pain score will be collected after drug administration	0-20 minutes after drug administration	No
Secondary	Provider satisfaction score	Provider satisfaction collected via survey post drug administration	0-20 minutes after drug administration	No
Secondary	Patient satisfaction	Patient satisfaction collected via survey post drug administration	0-20 minutes after drug administration	No