Actively Recruiting
IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED
Led by University of Oklahoma · Updated on 2024-06-28
90
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.
CONDITIONS
Official Title
IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 5 years old
- Presents to the emergency department for suture repair of lacerations 5 cm or smaller
- Parent(s) or caregiver(s) speak English
You will not qualify if you...
- Younger than 12 months or older than 5 years
- Lacerations longer than 5 cm requiring suture repair
- Known allergy or adverse reaction to Midazolam, Dexmedetomidine, Ketamine, or other sedatives
- Abnormal vital signs for age, especially heart rate and blood pressure
- History of cardiac, respiratory, renal, or liver disease
- Known electrolyte abnormalities
- Any eye trauma, nasal injury or deformity, significant nasal congestion, oral mucosa abnormalities, facial deformity or injury
- Taking beta blockers or other blood pressure lowering medications
- Classified as American Society of Anesthesiologists III or above
- Known or expected difficult airway
- Abnormal neurological examination
- Parent(s) or caregiver(s) do not speak English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
G
Gavely Toor, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here