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

Primary Purpose

Conscious Sedation, Simple Lacerations Less Than 4 cm, Lumbar Punctures

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Nitrous Oxide

Midazolam

About this trial

This is an interventional other trial for Conscious Sedation

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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
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
2. Intranasal Midazolam 0.4mg/kg with a max dose of 10mg

Exclusion Criteria:

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:
1. pneumothorax,
2. air embolus,
3. pneumocephalus, or
4. craniotomy in the last 3 weeks,
5. intraocular surgery with retained gas,
6. pulmonary bullae,
7. severe emphysema, or
8. bowel obstruction.
Patients with significant co-morbidities:
1. severe pulmonary disease,
2. cardiac disease,
3. hematologic diseases associated with B12 deficiency,
4. sickle cell disease.
Patients with acute otitis media and/or sinusitis
History of paradoxical reaction to nitrous oxide
Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients
Co-administration of additional sedation or analgesic medications

Sites / Locations

Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Nitrous Oxide

Intranasal Midazolam

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Patient/parent satisfaction will be assessed for all patients; child satisfaction will be assessed for patients over 12 years of age. Satisfaction will be measured on a scale of 1 to 5 (1 being not satisfied and 5 being very satisfied). Specifically, parents (and children when applicable) will be asked "how satisfied with the means of sedation were you for the procedure performed". Research assistants will then ask the ED providers on a scale of 1 to 5 (1 being not satisfied and 5 being very satisfied) "how satisfied with the means of sedation were you for the procedure performed".

Adverse Events.

Number of adverse events observed. Adverse events will be classified and defined as hypoxia, need for administration of reversal agent, nausea, vomiting, paradoxical reaction, airway obstruction, laryngospasm, inadequate sedation, allergic reaction, and cardiac arrest.

Full Information

NCT ID

NCT03085563

First Posted

October 21, 2016

Last Updated

April 14, 2022

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT03085563

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

May 24, 2017 (Actual)

Primary Completion Date

November 8, 2018 (Actual)

Study Completion Date

November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nitrous Oxide

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intranasal Midazolam

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nitrous Oxide

Other Intervention Name(s)

N2O

Intervention Description

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%.

Intervention Type

Drug

Intervention Name(s)

Midazolam

Other Intervention Name(s)

Versed

Intervention Description

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.

Primary Outcome Measure Information:

Title

ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Time of discharge, Approximately 2 hours

Title

Adverse Events.

Description

Time Frame

Time of discharge, Approximately 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 craniotomy in the last 3 weeks, intraocular surgery with retained gas, pulmonary bullae, severe emphysema, or bowel obstruction. Patients with significant co-morbidities: severe pulmonary disease, cardiac disease, hematologic diseases associated with B12 deficiency, sickle cell disease. Patients with acute otitis media and/or sinusitis History of paradoxical reaction to nitrous oxide Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients Co-administration of additional sedation or analgesic medications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul A Szefler, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

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

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