A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department

NCT03085563 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-1909
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to compare the sedative effects of intranasal midazolam versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency department. The primary outcome will be length of stay (LOS) in the emergency department (ED) stay for minor procedures. Secondarily the investigators will compare patient/family and provider satisfaction while using either intranasal midazolam or N2O for minimal sedation. The investigators hypothesize that the total length of stay for children undergoing minor procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The investigators also hypothesize that patient/family and provider satisfaction will be higher with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients will receive either intranasal midazolam or N2O for minor procedures. Following the enrollment period, data will be analyzed and the two will be compared. Total length of stay, patient/family and provider satisfaction will be studied.

Conditions

Conscious Sedation; Simple Lacerations Less Than 4 cm; Lumbar Punctures; Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement

Outcome Measures

Primary Outcomes (1)

• ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration

  The total length of Emergency Department (ED) stay will be defined as time from intranasal midazolam or nitrous oxide administration to time of discharge readiness, collected by the research assistants. Additional time periods measured will include: time from anxiolytic/sedative given to time of procedure completion, and total time for recovery.

  From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours.

Secondary Outcomes (2)

• Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative.

  Time of discharge, Approximately 2 hours

• Adverse Events.

  Time of discharge, Approximately 2 hours

Study Arms (2)

Nitrous Oxide

ACTIVE COMPARATOR

Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.

Drug: Nitrous Oxide

Intranasal Midazolam

ACTIVE COMPARATOR

Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.

Drug: Midazolam

Interventions

Nitrous Oxide DRUG

Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%.

Also known as: N2O

Nitrous Oxide

Midazolam DRUG

Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures.

Also known as: Versed

Intranasal Midazolam

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients ≥2 years of age and \<18 years of age, and
• Parent/legal guardian age ≥18 years of age to \<80 years of age
• Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System level 1, 2, and 3
• Patients requiring anxiolysis and mild sedation for minor procedures
• Minor procedures will include simple lacerations less than 4 cm
• Lumbar punctures
• Minor incision
• Drainage of abscesses that do not require extensive debridement
• Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam.
• Nitrous oxide up to 70% nitrous concentration will be allowed
• Intranasal Midazolam 0.4mg/kg with a max dose of 10mg

You may not qualify if:

• Nasal injury, nasal obstruction or significant congestion
• Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing
• Allergy to benzodiazepines
• Benzodiazepine dosing for any reason 24 hours prior to procedure
• Excessive Epistaxis
• Facial or nasal deformity
• Copious mucous
• Recent (less than 1 week) tympanic membrane graft or middle ear surgery
• Recent bleomycin therapy
• Patients known to be pregnant at time of enrollment
• Patients with severe behavior problems, personality disorders or other mind-altering conditions as determined by administering provider.
• Closed space situations such as:
• pneumothorax,
• air embolus,
• pneumocephalus, or

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Nitrous Oxide; Midazolam

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paul Szefler, MD, FAAP
• Organization: Children's Hospital Colorado

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Paul A Szefler, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: March 21, 2017
• Study Start: May 24, 2017
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: May 10, 2022
• Results First Posted: May 10, 2022

Record last verified: 2022-04

Locations

US (1)