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Nasal Spray Sedation for Procedural Anxiety

Phase 1 & 2

Recruiting

Led By Daniel S Tsze, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Attending physician has decided intranasal midazolam indicated to facilitate repair

Simple laceration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study drug administration until patient discharge (approximately 120 minutes)

Awards & highlights

Study Summary

This trial is testing different doses of midazolam given as a nasal spray to see how well it works for sedation in children during laceration repair.

Who is the study for?

This trial is for children aged 6 months to 7 years who need sedation for simple laceration repair. It's not suitable for kids with eyelid, tongue, or intraoral cuts, developmental delays, nasal blockages that can't be cleared, chronic pain illnesses, benzodiazepine allergies, autism spectrum disorder, neurological abnormalities or those using tissue adhesives/staples.Check my eligibility

What is being tested?

The study tests different doses of intranasal midazolam (0.2-0.5 mg/kg) in children to find the most effective dose for sedation during laceration repair. It aims to determine the best dose for adequate sedation and how quickly it works as well as recovery time and any adverse events.See study design

What are the potential side effects?

Possible side effects of intranasal midazolam may include drowsiness after the procedure has finished, changes in mood or behavior temporarily during recovery period and less commonly respiratory issues like coughing or wheezing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor has prescribed a nasal spray sedative for my procedure.

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I have a simple cut.

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I am between 6 months and 7 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study drug administration until patient discharge (approximately 120 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study drug administration until patient discharge (approximately 120 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study drug administration until patient discharge (approximately 120 minutes) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pediatric Sedation State Scale Score

Time to onset of minimal sedation

Secondary outcome measures

Incidence of adverse events

OSBD-R Scale Score

Time to recovery

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: 0.5 mg/kgExperimental Treatment1 Intervention

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg.

Group II: 0.4 mg/kgExperimental Treatment1 Intervention

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg.

Group III: 0.3 mg/kgExperimental Treatment1 Intervention

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg.

Group IV: 0.2 mg/kgExperimental Treatment1 Intervention

Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mailman School of Public HealthUNKNOWN

2 Previous Clinical Trials

1,009 Total Patients Enrolled

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,683 Total Patients Enrolled

Emergency Medicine FoundationOTHER

17 Previous Clinical Trials

2,235 Total Patients Enrolled

Media Library

Intranasal midazolam Clinical Trial Eligibility Overview. Trial Name: NCT04586504 — Phase 1 & 2

Procedural Anxiety Research Study Groups: 0.5 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg

Procedural Anxiety Clinical Trial 2023: Intranasal midazolam Highlights & Side Effects. Trial Name: NCT04586504 — Phase 1 & 2

Intranasal midazolam 2023 Treatment Timeline for Medical Study. Trial Name: NCT04586504 — Phase 1 & 2

Frequently Asked Questions

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

Does this study have an age limit?

"This particular clinical trial only accepts patients that are 6 months to 7 years old. Out of the total 70 trials, 29 of them focus on a paediatric population while 41 study adults 65 and older."

Answered by AI

What benefits does this experiment hope to bring patients?

"The purpose of this study, which will last around 60 minutes, is to understand how long it takes for patients to reach a minimal level of sedation. The University of Michigan Sedation Scale (UMSS) and the Observational Scale of Behavioral Distress - Revised (OSBD-R) will be used in order to measure depth of sedation and procedural pain/distress respectively. Time to recovery is defined as the amount of time from when the procedure finishes until the patient meets Simplified Aldrete Score criteria for being recovered."

Answered by AI

Are researchers still looking for participants in this trial?

"Yes, this is an ongoing study that was first posted on September 8th, 2021. The last update to the posting occurred on October 10th, 2022. They are currently recruiting for 150 participants from 1 site."

Answered by AI

Are there other peer-reviewed research papers that explore Intranasal midazolam?

"Currently, there are 68 active studies researching Intranasal midazolam. 10 of those studies are in Phase 3. Many of the trials for Intranasal midazolam are based in Porto Alegre, California, but there are 699 locations running studies for this treatment globally."

Answered by AI

How many people have been asked to participate in this clinical trial?

"The information on clinicaltrials.gov does support that this study is looking for new participants as of 10/10/2022. The original posting date was 9/8/2021 and the trial is being conducted at 1 location with a goal recruitment number of 150 patients."

Answered by AI

How can I become a test subject for this experiment?

"This clinical trial is testing a new intervention for anxiety in children aged 6 months to 7 years old. They are looking for approximately 150 participants."

Answered by AI