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Alpha-2 Agonist
Oral Dexmedetomidine for Pediatric Anesthesia
Phase 1
Waitlist Available
Led By Soroush Merchant, MD, MS
Research Sponsored by Children's Mercy Hospital Kansas City
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 immediately after the mri scan completion
Awards & highlights
Study Summary
This trial is testing if a drug can be used to sedate kids for an MRI scan without any other drugs.
Who is the study for?
This trial is for children aged 4 months to 6 years who need anesthesia for an MRI. They must not be using digoxin, have craniofacial anomalies, recent apnea, or severe medical conditions that make sedation risky. Kids with allergies to dexmedetomidine or certain heart and respiratory diseases can't participate.Check my eligibility
What is being tested?
The study is testing if oral dexmedetomidine alone can safely sedate kids during an MRI. It's a preliminary test to see if this method works without needing other general anesthetics.See study design
What are the potential side effects?
Dexmedetomidine may cause side effects like low blood pressure, slow heart rate, dry mouth, drowsiness or nausea in some children. The exact side effects will be monitored closely in the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during and immediately after the intervention procedure. assessments will cease once rss return to 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during and immediately after the intervention procedure. assessments will cease once rss return to 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MRI motion artifact
Secondary outcome measures
Ramsay Sedation Score (RSS) of 4
Side effects data
From 2020 Phase 4 trial • 798 Patients • NCT0200461357%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Dexmedetomidine 24 mcg/kgExperimental Treatment1 Intervention
Group Three: Subjects will receive oral dexmedetomidine 24 mcg/kg 2 hours prior to MRI
Group II: Dexmedetomidine 18 mcg/kgExperimental Treatment1 Intervention
Group Two: Subjects will receive oral dexmedetomidine 18 mcg/kg 2 hours prior to MRI
Group III: Dexmedetomidine 12 mcg/kgExperimental Treatment1 Intervention
Group One: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI
Group IV: General anesthesia controlActive Control1 Intervention
Control group: Subjects will receive general anesthesia for their MRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~1980
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,679 Total Patients Enrolled
Soroush Merchant, MD, MSPrincipal InvestigatorChildren's Mercy Hospital Kansas City
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently had a stroke.I am between 4 months and 6 years old.I refuse to take oral dexmedetomidine.I cannot take dexmedetomidine 90 minutes before an MRI.I am currently taking digoxin.I have been diagnosed with Moya Moya disease.I cannot be given sedatives due to health reasons.I am scheduled for an MRI with anesthesia for medical reasons.I cannot take dexmedetomidine due to health reasons.I do not have serious heart problems or life-threatening irregular heartbeats.I am currently experiencing frequent and uncontrollable vomiting.I currently have an active lung or breathing issue.I have a current or recent history of apnea.I have severe and unmanaged acid reflux.
Research Study Groups:
This trial has the following groups:- Group 1: Dexmedetomidine 18 mcg/kg
- Group 2: General anesthesia control
- Group 3: Dexmedetomidine 12 mcg/kg
- Group 4: Dexmedetomidine 24 mcg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process for this investigation still open?
"According to clinicaltrials.gov, this investigation is not presently recruiting patients - it was initially announced on 1/1/2023 and the latest update was 11/16/2022. While this trial is inactive, there are 126 other trials actively searching for participants at present."
Answered by AI
Is the age limitation for this study 45 years or younger?
"This trial is accessible to paediatric patients aged between 4 Months and 6 years. Moreover, there are 32 sub-studies for minors and 93 trials for elderly people over 65."
Answered by AI
Is it permissible for me to register for this clinical experiment?
"In order to qualify for this trial, participants must have received anaesthesia treatment and be within the 4 month - 6 year age range. This study is currently recruiting 120 patients in total."
Answered by AI
Does the dosage of 12 mcg/kg for Dexmedetomidine present any significant risks to individuals?
"Given the limited clinical data surrounding this medication, Dexmedetomidine 12 mcg/kg was given a score of 1 on our safety scale. This shows it is in its initial trial phase and there are few results assessing its efficacy or safety."
Answered by AI
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