RecruitingPhase 4NCT05934669

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

Sponsor

University of Oklahoma

Enrollment

90 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

Conditions

Anxiety Laceration of Skin Discharge Time

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

Min Age: 1 YearMax Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three nasal (nose spray) medications — midazolam, dexmedetomidine, and ketamine — used to calm young children during minor medical procedures in the emergency department, such as stitching up small cuts. **You may be eligible if...** - Your child is aged 1–5 years old - Your child is being seen in the emergency department for a small cut (laceration 5 cm or less) that needs stitches - You (the parent or caregiver) speak English **You may NOT be eligible if...** - Your child is under 12 months or older than 5 years - The cut is longer than 5 cm - Your child has a known allergy or bad reaction to any of the three study medications (midazolam, dexmedetomidine, ketamine, or other sedatives) - Your child has heart, lung, kidney, or liver disease - Your child has abnormal heart rate or blood pressure - Your child has nasal injury, significant nasal congestion, eye trauma, or facial deformities - Your child takes beta blockers or similar heart medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntranasal Midazolam

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.

DRUGIntranasal Dexmedetomidine

See above

DRUGIntranasal Ketamine

See above