Actively Recruiting

Phase 4
Age: 1Year - 5Years
All Genders
Healthy Volunteers
ID05934669

Randomized Controlled Trial of Intranasal Midazolam vs Dexmedetomidine vs Ketamine Evaluating Length of Stay and Anxiolysis During Pediatric Procedures in Emergency Department

Led by University of Oklahoma · Updated on 2024-06-28

90

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pain in young children is often under-recognized because they cannot clearly describe or locate it. This research is evaluating three intranasal medications—Midazolam, Dexmedetomidine, and Ketamine—to compare how long children stay in the emergency department after receiving these treatments for laceration repairs. The study aims to find which medication offers the best anxiety relief with the shortest hospital stay and highest satisfaction for patients and providers. Participants will be randomly assigned to receive one of three intranasal drugs: Midazolam, Dexmedetomidine, or Ketamine. Midazolam is commonly used but can cause nasal irritation and side effects like respiratory depression. Dexmedetomidine mimics sleep and is preferred for children with behavioral concerns, while Ketamine provides both anxiety relief and pain control. Dosing is weight-based, and medications are administered via a syringe designed to deliver small volumes to the nostrils. All three drugs are being studied for their effects during minor procedures in a pediatric emergency setting. Children aged 1 to 5 years with small lacerations will be monitored during their emergency department visit. Researchers will assess the time from medication administration to discharge, measure anxiety levels using the Modified Yale Preoperative Anxiety Scale (mYPAS), and gather satisfaction ratings from parents and physicians. Safety checks include monitoring vital signs and watching for side effects. The total participation is limited to the emergency visit day, with careful observation throughout the procedure and recovery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 1-5 years old
  • Presenting to the emergency department for suture repair of lacerations 5cm or smaller
  • Parent(s) or caregiver(s) speak English
Not Eligible

You will not qualify if you...

  • Younger than 12 months or older than 5 years
  • Lacerations larger than 5cm needing sutures
  • Known allergy or adverse reaction to Midazolam, Dexmedetomidine, Ketamine, or other sedatives
  • Abnormal vital signs for age, especially heart rate and blood pressure
  • History of heart, lung, kidney, or liver disease
  • Known electrolyte imbalances
  • Any eye injury, nasal deformity, congestion, mucosa abnormalities, facial deformity, or facial injury
  • Taking beta blockers or other blood pressure-lowering medications
  • Classified as American Society of Anesthesiologists III or higher
  • Known or expected difficult airway
  • Abnormal neurological exam
  • Parent(s) or caregiver(s) do not speak English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day 1

Participants receive one of three intranasal medications (Midazolam, Dexmedetomidine, or Ketamine) prior to minimal procedures in the pediatric emergency department to provide anxiolysis and facilitate procedure completion.

1 baseline visit (in-person) for medication administration and procedure

Follow-up

Duration - Same day as treatment (Day 1)

Participants are observed until discharge after medication administration to evaluate time to discharge, patient anxiety, and satisfaction of parents and physicians.

1 follow-up visit (in-person) on the same day

Trial Site Locations

Total: 1 location

1

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

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Research Team

G

Gavely Toor, DO

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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Published Research Related To This Trial

Relief of pain and anxiety in pediatric patients in emergency medical systems.

William T Zempsky, Joseph P Cravero, American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine

https://pubmed.ncbi.nlm.nih.gov/15520120

Intramuscular Dexmedetomidine, a Feasible Option for Children With Autism Spectrum Disorders Needing Urgent Procedural Sedation.

Giorgia Carlone, Andrea Trombetta, Stefano Amoroso...

https://pubmed.ncbi.nlm.nih.gov/31157751

Comparing Sedative Effect of Dexmedetomidine versus Midazolam for Sedation of Children While Undergoing Computerized Tomography Imaging.

Reza Azizkhani, Farhad Heydari, Mohammadreza Ghazavi...

https://pubmed.ncbi.nlm.nih.gov/33531939

Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department.

Desiree N W Neville, Katharina R Hayes, Yaron Ivan...

https://pubmed.ncbi.nlm.nih.gov/27129606

Comparison between intranasal dexmedetomidine and intranasal ketamine as premedication for procedural sedation in children undergoing MRI: a double-blind, randomized, placebo-controlled trial.

Prakhar Gyanesh, Rudrashish Haldar, Divya Srivastava...

https://pubmed.ncbi.nlm.nih.gov/23800984