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Completed

NCT Number: NCT03085563

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

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.

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Key information

Conditions

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

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%.

Other names: N2O

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.

Other names: Versed

Primary outcomes

  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 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 outcomes

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

    Time frame: Time of discharge, Approximately 2 hours

    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".

  2. Adverse Events.

    Time frame: Time of discharge, Approximately 2 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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