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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

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

Treatments: Drug: Midazolam; Drug: Nitrous Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03085563

16-1909

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No 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
   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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Nitrous Oxide

Active Comparator group

Description:

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

Treatment:

Drug: Nitrous Oxide

Intranasal Midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam