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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity of Oklahoma

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intranasal Midazolam
  • Intranasal Dexmedetomidine
  • Intranasal Ketamine

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators