Effectiveness of Nitrous Oxide in the ED

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lacerations; Abscess
• Intervention / Treatment: Drug: Nitrous Oxide; Other: Oxygen

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nitrous Oxide; Patients receive nitrous oxide via mask.	Drug: Nitrous Oxide
Placebo Comparator: Placebo (Oxygen); Patients receive oxygen via mask.	Other: Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Assessment Scale (0-10)	Pain score will be collected after drug administration	0-20 minutes after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider satisfaction score	Provider satisfaction collected via survey post drug administration	0-20 minutes after drug administration
Patient satisfaction	Patient satisfaction collected via survey post drug administration	0-20 minutes after drug administration

Collaborators and Investigators

• Sponsor: Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 602966

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO