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

PHASE4CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

May 24, 2017

Primary Completion Date

November 8, 2018

Study Completion Date

November 8, 2018

Conditions
Conscious SedationSimple Lacerations Less Than 4 cmLumbar PuncturesMinor Incision Drainage of Abscesses Not Requiring Extensive Debridement
Interventions
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%.

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.

Trial Locations (1)

80045

Children's Hospital Colorado, Aurora

All Listed Sponsors
lead

University of Colorado, Denver

OTHER

NCT03085563 - A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department | Biotech Hunter | Biotech Hunter