Nitrous Oxide Use in Minor Procedures

NCT01911351 | Completed Results DMC

• 1 other identifier: 2013-296
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Title: High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety during pediatric minor procedures. Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in addition to standard management increases the comfort level in pediatric patients undergoing minor procedures compared to standard management alone.

Conditions

Laceration; Abscess

Keywords

nitrous oxide; pediatric pain and anxiety

Outcome Measures

Primary Outcomes (1)

• FLACC Pain Scale

  The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.

  peak pain during procedure approximately 2-5 minutes into the procedure

Secondary Outcomes (1)

• M-YPAS Anxiety Scale

  measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure

Other Outcomes (3)

• Length of the Procedure

  measure time duration of each procedure, average 5-15 minutes

• Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure

  measured at the end of each procedure, approximately 10 minutes after the procedure is completed

• Percentage of Providers Who Rated the Procedure as Being Successful

  measured at the end of each procedure, approximately 10 minutes after the completion of the procedure

Study Arms (2)

standard management

NO INTERVENTION

Patients randomized to this arm will receive standard management alone for their minor procedure.

Nitrous Oxide

EXPERIMENTAL

Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.

Drug: Nitrous Oxide

Interventions

Nitrous Oxide DRUG

Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.

Also known as: nitronox

Nitrous Oxide

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Minor Procedure
• Age 3 - 12 years

You may not qualify if:

• Behavioral Disorders
• Anxiety Score \<10

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Lacerations; Abscess; Anxiety Disorders

Interventions

Nitrous Oxide; Entonox

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sandra Cunningham
• Organization: NYCHHC Jacobi Medical Center

sandra.cunningham@nbhn.net

718 918 5250

Study Officials

• Sandra Cunningham, MD

  Jacobi Medical Center - NYHHC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-02

Locations

US (1)