Effectiveness of Nitrous Oxide in the ED

NCT02703233 | Withdrawn Phase 4

• 1 other identifier: 602966
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lacerations; Abscess

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Assessment Scale (0-10)

  Pain score will be collected after drug administration

  0-20 minutes after drug administration

Secondary Outcomes (2)

• Provider satisfaction score

  0-20 minutes after drug administration

• Patient satisfaction

  0-20 minutes after drug administration

Study Arms (2)

Nitrous Oxide

ACTIVE COMPARATOR

Patients receive nitrous oxide via mask.

Drug: Nitrous Oxide

Placebo (Oxygen)

PLACEBO COMPARATOR

Patients receive oxygen via mask.

Other: Oxygen

Interventions

Nitrous Oxide DRUG

Nitrous Oxide

Oxygen OTHER

Placebo (Oxygen)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Christiana Care Health Services: lead

MeSH Terms

Conditions

Lacerations; Abscess

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Wounds and Injuries; Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Officials

• Brian Levine, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share