A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- Nitrous Oxide
- Conditions
- Conscious Sedation
- Sponsor
- University of Colorado, Denver
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
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
Arms & Interventions
Nitrous Oxide
Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.
Intervention: Nitrous Oxide
Intranasal Midazolam
Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.
Intervention: Midazolam
Outcomes
Primary Outcomes
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
- Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative.(Time of discharge, Approximately 2 hours)
- Adverse Events.(Time of discharge, Approximately 2 hours)