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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Laceration of Skin
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Oklahoma,

Ryan Mckee, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

2025-06