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

COMPLETEDPHASE4

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

NCT03085563•University of Colorado, Denver

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Nasal injury, nasal obstruction or significant congestion
•2. Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing
•3. Allergy to benzodiazepines
•4. Benzodiazepine dosing for any reason 24 hours prior to procedure
•5. Excessive Epistaxis
•6. Facial or nasal deformity
•7. Copious mucous
•8. Recent (less than 1 week) tympanic membrane graft or middle ear surgery
•9. Recent bleomycin therapy
•10. Patients known to be pregnant at time of enrollment
+19 more criteria

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Key Dates

Start Date

May 24, 2017

Primary Completion Date

November 8, 2018

Completion Date

November 8, 2018

Last Updated

May 10, 2022

Enrollment

ACTUAL participants

Conditions

Conscious SedationSimple Lacerations Less Than 4 cmLumbar PuncturesMinor Incision Drainage of Abscesses Not Requiring Extensive Debridement

Interventions

Nitrous Oxide

DRUG

Midazolam

DRUG

TEAS for Sedation During ERCP

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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