Oral Dexmedetomidine in Pediatric MRI

April 7, 2026 updated by: Soroush Merchant

Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

MRI is an important and robust medical imaging technique that has become the cornerstone for radiologic studies. Superior image quality and resolution especially for soft tissue imaging, without the use of ionizing radiation, has made MRI a dominant imaging modality in pediatrics. Despite its many advantages, MRI is not child friendly. Lengthy scan times, the need for lying motionless in a confined space, excessive noise and vibration during image acquisition, are all factors that have made anesthesia an integral part of pediatric MRI.

General anesthesia is a state of medically induced unconsciousness, analgesia and muscle relaxation which is required for most invasive medical procedures. Despite being painless, MRI scans are highly susceptible to motion artifact and require a state of immobility that may not be obtainable in awake uncooperative children. While very safe, general anesthesia carries potential risk of serious morbidity and mortality secondary to aspiration during instrumentation of the airway, hypoxia and hypoventilation secondary to laryngospasm/bronchospasm and hemodynamic instability. Therefore, sedation may be an appropriate technique to offer anxiolysis, amnesia and immobility while maintaining airway reflexes with limited impact on ventilation and hemodynamics for non-stimulating procedures such as imaging. Aside from having a more favorable risk/benefit profile as compared to general anesthesia when it comes to radiologic studies, sedation is also less costly and burdensome on anesthesia departments and could provide immense cost-saving measures for healthcare institutions at large.

While there are many intravenous (IV) sedatives, establishing IV access while awake could be very traumatizing, leaving a lasting negative impression of the healthcare environment in a child's mind. Hence, enteral medications may be more acceptable and child friendly. This is especially valuable in patients who require repeated surveillance imaging and who demonstrate heightened level of anxiety and fear with each visit. Among sedative agents that could be administered enterally, dexmedetomidine may be superior due to minimal respiratory depression while providing anxiolysis and analgesia. Of note, dexmedetomidine is a highly selective alpha2-adrenoreceptor agonist that exerts its hypnotic action through activation of central pre- and postsynaptic alpha2-receptors in the locus coeruleus, mimicking natural sleep.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kelsye Howell, MSN, RN
  • Phone Number: 816-760-5919
  • Email: klhowell@cmh.edu

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Soroush Merchant, MD, MS
        • Sub-Investigator:
          • Kristin Leland, MD

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.

Eligibility Criteria

Ages Eligible for Study

4 months to 6 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants 3-6 years old, male and female, all races and ethnicities
  2. Requiring a clinically indicated MRI with general anesthesia

Exclusion Criteria:

  1. Refusal to take oral dexmedetomidine
  2. Known allergy to dexmedetomidine
  3. Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI

  4. Medical contraindications to administration of dexmedetomidine including:

    1. Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction
    2. Current use of digoxin
    3. Moya Moya disease
    4. New onset stroke
  5. American Society of Anesthesiologists (ASA) physical status classification > II

  6. Contraindications to administering sedation including:

    1. Active and uncontrolled gastroesophageal reflux
    2. Active and uncontrolled vomiting
    3. Current or recent history of apnea
    4. Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation
    5. Craniofacial anomalies
  7. Inability to have MRI scans
  8. Non-English speaking volunteers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine 4 mcg/kg
Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI
Drug: Dexmedetomidine
Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
Experimental: Dexmedetomidine 6 mcg/kg
Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI
Drug: Dexmedetomidine
Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
Experimental: Dexmedetomidine 8 mcg/kg
Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI
Drug: Dexmedetomidine
Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
Experimental: Dexmedetomidine 10 mcg/kg
Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI
Drug: Dexmedetomidine
Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
Experimental: Dexmedetomidine 12 mcg/kg
Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI
Drug: Dexmedetomidine
Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
Active Comparator: General anesthesia
Control group: Subjects will receive general anesthesia for their MRI
Drug: General Anesthesia (control group)
Participants will receive general anesthesia for their MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study
Time Frame: From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks
The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).
From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ramsay Sedation Score (RSS) of 4
Time Frame: During and immediately after the intervention procedure. Assessments will cease once RSS return to 3
The secondary outcome is achieving a minimum Ramsay Sedation Score (RSS) of 4
During and immediately after the intervention procedure. Assessments will cease once RSS return to 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroush Merchant

Investigators

  • Principal Investigator: Soroush Merchant, MD, MS, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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