A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedure… (NCT03085563) | Clinical Trial Compass
CompletedPhase 4
A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
United States63 participantsStarted 2017-05-24
Plain-language 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.
Who can participate
Age range2 Years – 17 Years
SexALL
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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
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
What they're measuring
1
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.