RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-14
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05934669

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.

Ages Eligible for Study:1 Year to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age 1-5 years old
  2. * Presents to the ED for suture repair for lacerations less than or equal to 5cm in length
  3. * Parent(s)/Caregiver(s) speak English
  1. * Younger than 12 months of age or older than 5 years old
  2. * Suture repair needed for lacerations are greater than 5cm in length
  3. * Known allergy or adverse effect to Midazolam, Dexmedetomidine, Ketamine, or any other sedatives
  4. * Any abnormal vital signs for age, especially heart rate and blood pressure
  5. * History of Cardiac, respiratory, renal, or liver disease
  6. * Known electrolyte abnormalities
  7. * Any ocular trauma, nasal injury, nasal deformity, significant nasal congestion, abnormalities in the nasal or oral mucosa, facial deformity, or facial injury
  8. * Home medications include beta blockers or any other blood pressure lowering agents Classified American Society of Anesthesiologists III and above
  9. * Known or anticipated difficult airway
  10. * Abnormal neurological exam
  11. * Parent(s)/Caregiver(s) do not speak English

Contacts and Locations

Study Contact

Gavely Toor, DO
CONTACT
405-271-2429
gavely-toor@ouhsc.edu

Principal Investigator

Ryan Mckee, MD
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Ryan Mckee, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

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

Study Start Date2023-11-14
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-11-14
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Laceration of Skin
  • Anxiety
  • Discharge Time