Clinical trial NCT03085563: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conscious Sedation
Simple Lacerations Less Than 4 cm
Lumbar Punctures
Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 63
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration
timeFrame: From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours.
Secondary outcomes:
measure: Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative.
timeFrame: Time of discharge, Approximately 2 hours
measure: Adverse Events.
timeFrame: Time of discharge, Approximately 2 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Paul A Szefler, MD
role: PRINCIPAL_INVESTIGATOR
References: