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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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ClinicalTrials.gov Identifier: NCT03085563
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Conscious Sedation Simple Lacerations Less Than 4 cm Lumbar Punctures Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement Drug: Nitrous Oxide Drug: Midazolam Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitrous Oxide
Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.
Drug: Nitrous Oxide
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%.
Other Name: N2O

Active Comparator: Intranasal Midazolam
Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.
Drug: Midazolam
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.
Other Name: Versed




Primary Outcome Measures :
  1. ED Length of Stay after intranasal midazolam or nitrous oxide administration [ Time Frame: From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours. ]
    The total length of 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 :
  1. Patient/parent and provider satisfaction with sedation and anxiolytic/sedative. [ Time Frame: Time of discharge, Approximately 2 hours ]
    Patient/parent and provider satisfaction will be assessed with a short questionnaire.

  2. Patient/parent and provider satisfaction with sedation and adverse events. [ Time Frame: Time of dischrge, Approximatley 2 hours ]
    Patient/parent and provider satisfaction will be assessed with a short questionnaire.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  11. Patients with severe behavior problems, personality disorders or other mind-altering conditions as determined by administering provider.
  12. 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.
  13. Patients with significant co-morbidities:

    1. severe pulmonary disease,
    2. cardiac disease,
    3. hematologic diseases associated with B12 deficiency,
    4. sickle cell disease.
  14. Patients with acute otitis media and/or sinusitis
  15. History of paradoxical reaction to nitrous oxide
  16. Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients
  17. Co-administration of additional sedation or analgesic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085563


Contacts
Contact: Joseph Wathen, MD 303-493-8333 joseph.wathen@childrenscolorado.org
Contact: Kathleen Grice, BS 303-724-3285 kathleen.grice@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Joseph Wathen, MD    303-493-8333    joseph.wathen@childrenscolorado.org   
Contact: Paul Szefler, MD    303-898-5895    paul.szefler@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Paul A Szefler, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03085563     History of Changes
Other Study ID Numbers: 16-1909
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Emergencies
Lacerations
Disease Attributes
Pathologic Processes
Wounds and Injuries
Midazolam
Nitrous Oxide
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents