A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
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|ClinicalTrials.gov Identifier: NCT03085563|
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Conscious Sedation Simple Lacerations Less Than 4 cm Lumbar Punctures Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement||Drug: Nitrous Oxide Drug: Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department|
|Actual Study Start Date :||May 24, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Nitrous Oxide
Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.
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%.
Other Name: N2O
Active Comparator: Intranasal Midazolam
Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.
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 Name: Versed
- 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 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.
- Patient/parent and provider satisfaction with sedation and anxiolytic/sedative. [ Time Frame: Time of discharge, Approximately 2 hours ]Patient/parent and provider satisfaction will be assessed with a short questionnaire.
- Patient/parent and provider satisfaction with sedation and adverse events. [ Time Frame: Time of dischrge, Approximatley 2 hours ]Patient/parent and provider satisfaction will be assessed with a short questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085563
|Contact: Joseph Wathen, MDemail@example.com|
|Contact: Kathleen Grice, BSfirstname.lastname@example.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Joseph Wathen, MD 303-493-8333 email@example.com|
|Contact: Paul Szefler, MD 303-898-5895 firstname.lastname@example.org|
|Principal Investigator:||Paul A Szefler, MD||University of Colorado, Denver|