IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED
Randomized Controlled Trial of Intranasal (IN) Midazolam vs IN Dexmedetomidine vs IN Ketamine Evaluating Length of Stay After Medication Administration and Anxiolysis During Minimal Procedures in Pediatric Population in Pediatric Emergency Department
University of Oklahoma
90 participants
Nov 14, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria11
- 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
Interventions
Using a computer-generated randomization schedule by the research pharmacist, all 90 subjects will be divided into 3 even groups to receive either medication A (intranasal Midazolam), B (intranasal Dexmedetomidine), or C (intranasal Ketamine). Based on the randomization schedule, the pharmacist will dispense medication A, B, or C to the chronological number provided in the order. The total amount of the medication will be based on the patient's charted weight. Small volumes of less than 1ml per nostril are preferred for reliable absorption; therefore, the medication will be dispensed in a 1ml syringe and the barrel of the syringe will be covered by the pharmacist. All the syringes sent from the pharmacy will appear the same, regardless of the volume of the medication.
See above
See above
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05934669