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Alpha-2 Agonist

Intranasal Midazolam for Skin Lacerations

Phase 4

Recruiting

Led By Ryan Mckee, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

Study Summary

"This trial will compare three different medications administered through the nose to see which one helps children feel less anxious during procedures like getting stitches for cuts. The goal is to find the medication that not only reduces anxiety

Who is the study for?

This trial is for children aged 1-5 who need stitches for small cuts (up to 5cm) and are in the emergency department. Their parents or caregivers must speak English. It's not clear what conditions exclude someone from participating.Check my eligibility

What is being tested?

The study compares three nose-spray medications—Midazolam, Dexmedetomidine, and Ketamine—to see which one helps kids feel less anxious during minor procedures, gets them home fastest, and makes both families and doctors happiest with the process.See study design

What are the potential side effects?

Possible side effects of these nose sprays may include drowsiness, changes in mood or behavior, allergic reactions, nausea or vomiting. The exact side effects will depend on which medication is used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The will measure the time to discharge after intranasal medication administration

Secondary outcome measures

The will measure patient's anxiety using the previously validated scale mYPAS and physician and parent satisfaction using a 5-point Likert scale

Trial Design

3Treatment groups

Experimental Treatment

Group I: Intranasal MidazolamExperimental Treatment1 Intervention

Dose/Concentration: 5mg/ml of 0.4mg/kg Midazolam (max dose 10mg). Adverse side effects include respiratory depression and hypotension. Intranasal Midazolam is standard of care for minimal procedures in pediatric ED.

Group II: Intranasal KetamineExperimental Treatment1 Intervention

Dose/Concentration: 100mg/ml of 3mg/kg Ketamine (max dose 100mg). Adverse side effect include Laryngospasm. IV Ketamine is FDA approved and widely used in procedural sedation in pediatric EDs. IN form isn't FDA approved in pediatric population; however, it has also been approved to conduct research studies especially in combination with other medications. Gutherie et al conducted a study demonstrating intranasal Ketamine providing safe and successful anxiolysis in pediatric patients in an ED setting.

Group III: Intranasal DexmedetomidineExperimental Treatment1 Intervention

Dose/Concentration: 100mcg/ml of 2mcg/kg Dexmedetomidine (max dose 100mcg). Adverse side effects include Hypotension and Bradycardia at high dosages. IV Dexmedetomidine is FDA approved and widely used in sedation. IN form isn't FDA approved; however, it has been approved to conduct research studies that have showed its efficacy in pre-operative settings, imaging-CT or MRI, dental procedures, and much more. Specifically, in a pediatric ED setting, Neville et al conducted a study comparing intranasal Dexmedetomidine and intranasal Midazolam prior to laceration repair in a pediatric emergency department and showed safe administration of Dexmedetomidine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intranasal Dexmedetomidine

2019

Completed Phase 3

~210

Intranasal Midazolam

2019

Completed Phase 4

~140

Intranasal Ketamine

2014

Completed Phase 2

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,833 Total Patients Enrolled

Ryan Mckee, MDPrincipal InvestigatorUniversity of Oklahoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of participants still ongoing for this clinical trial?

"As per information from clinicaltrials.gov, this study is actively pursuing eligible participants. The trial was initially listed on 11/14/2023 and last revised on 3/1/2024."

Answered by AI

Am I eligible to be a part of this medical study?

"The trial is open to enrolling 90 pediatric participants aged between 1 and 5 years with skin lacerations. Eligible candidates must meet the following conditions: being within the age range of 1-5 years, seeking emergency department care for suturing of cuts up to or equal to a length of 5cm, and having English-speaking parent(s) or caregiver(s)."

Answered by AI

What are the potential risks of using Intranasal Dexmedetomidine for individuals?

"As a Phase 4 trial, the safety rating for Intranasal Dexmedetomidine is graded as 3 by our experts at Power due to its approved status."

Answered by AI

What is the total number of participants involved in this research endeavor?

"Indeed, information available on clinicaltrials.gov indicates that this research study is actively seeking volunteers. The trial was first listed on November 14th, 2023 and had its most recent update on March 1st, 2024. They aim to enroll around ninety participants at a single site."

Answered by AI

Is the enrollment for this study limited to individuals older than 25 years of age?

"Participants aged between 1 and 5 years are specifically sought for enrollment in this clinical research. Among the registered trials, there are 113 studies focused on pediatric participants under 18 years old, while there are also 297 trials tailored to individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934669.