IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED

RECRUITING

I'm interested ...!!

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:

Laceration of Skin Anxiety Discharge Time

Study Start (Actual) 2023-11-14

Primary Completion (Estimated) 2025-05

Study Completion (Estimated) 2025-06

Enrollment (Estimated) 90

Study Type INTERVENTIONAL

Phase PHASE4

Locations:

📍 Oklahoma City, Oklahoma, United States

Eligibility Criteria

Description

Inclusion Criteria:

* Age 1-5 years old
* Presents to the ED for suture repair for lacerations less than or equal to 5cm in length
* Parent(s)/Caregiver(s) speak English

Exclusion Criteria:

* Younger than 12 months of age or older than 5 years old
* Suture repair needed for lacerations are greater than 5cm in length
* Known allergy or adverse effect to Midazolam, Dexmedetomidine, Ketamine, or any other sedatives
* Any abnormal vital signs for age, especially heart rate and blood pressure
* History of Cardiac, respiratory, renal, or liver disease
* Known electrolyte abnormalities
* Any ocular trauma, nasal injury, nasal deformity, significant nasal congestion, abnormalities in the nasal or oral mucosa, facial deformity, or facial injury
* Home medications include beta blockers or any other blood pressure lowering agents Classified American Society of Anesthesiologists III and above
* Known or anticipated difficult airway
* Abnormal neurological exam
* Parent(s)/Caregiver(s) do not speak English

Ages Eligible for Study: 1 Year to 5 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-06-16
First Submitted that Met QC Criteria2023-06-28
First Posted2023-07-07

Study Record Updates

Last Update Submitted that Met QC Criteria2024-06-26
Last Update Posted2024-06-28
Last Verified2024-06