Oral Dexmedetomidine in Pediatric MRI

NCT05619627 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00002526
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia

Keywords

Oral dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study

  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

Study Arms (6)

Dexmedetomidine 4 mcg/kg

EXPERIMENTAL

Group One: Subjects will receive oral dexmedetomidine 4 mcg/kg 2 hours prior to MRI

Drug: Dexmedetomidine

Dexmedetomidine 6 mcg/kg

EXPERIMENTAL

Group Two: Subjects will receive oral dexmedetomidine 6 mcg/kg 2 hours prior to MRI

Drug: Dexmedetomidine

Dexmedetomidine 8 mcg/kg

EXPERIMENTAL

Group Three: Subjects will receive oral dexmedetomidine 8 mcg/kg 2 hours prior to MRI

Drug: Dexmedetomidine

Dexmedetomidine 10 mcg/kg

EXPERIMENTAL

Group Four: Subjects will receive oral dexmedetomidine 10 mcg/kg 2 hours prior to MRI

Drug: Dexmedetomidine

Dexmedetomidine 12 mcg/kg

EXPERIMENTAL

Group Five: Subjects will receive oral dexmedetomidine 12 mcg/kg 2 hours prior to MRI

Drug: Dexmedetomidine

General anesthesia

ACTIVE COMPARATOR

Control group: Subjects will receive general anesthesia for their MRI

Drug: General Anesthesia (control group)

Interventions

Dexmedetomidine DRUG

Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI

Dexmedetomidine 10 mcg/kg; Dexmedetomidine 12 mcg/kg; Dexmedetomidine 4 mcg/kg; Dexmedetomidine 6 mcg/kg; Dexmedetomidine 8 mcg/kg

General Anesthesia (control group) DRUG

Participants will receive general anesthesia for their MRI

General anesthesia

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Refusal to take oral dexmedetomidine
• Known allergy to dexmedetomidine
• Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI
• Medical contraindications to administration of dexmedetomidine including:
• Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction
• Current use of digoxin
• Moya Moya disease
• New onset stroke
• American Society of Anesthesiologists (ASA) physical status classification \> II
• Contraindications to administering sedation including:
• Active and uncontrolled gastroesophageal reflux
• Active and uncontrolled vomiting
• Current or recent history of apnea
• Active respiratory disease including pneumonia, bronchitis, respiratory syncytial virus infection, asthma exacerbation
• Craniofacial anomalies

Sponsors & Collaborators

• Soroush Merchant: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (16)

• Mason KP, Roback MG, Chrisp D, Sturzenbaum N, Freeman L, Gozal D, Vellani F, Cavanaugh D, Green SM. Results from the Adverse Event Sedation Reporting Tool: A Global Anthology of 7952 Records Derived from >160,000 Procedural Sedation Encounters. J Clin Med. 2019 Dec 1;8(12):2087. doi: 10.3390/jcm8122087.

  PMID: 31805686 BACKGROUND

• Mason KP, Green SM, Piacevoli Q; International Sedation Task Force. Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from the World SIVA International Sedation Task Force. Br J Anaesth. 2012 Jan;108(1):13-20. doi: 10.1093/bja/aer407.

  PMID: 22157446 BACKGROUND

• Sajid B, Mohamed T, Jumaila M. A comparison of oral dexmedetomidine and oral midazolam as premedicants in children. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):36-40. doi: 10.4103/joacp.JOACP_20_18.

  PMID: 31057237 BACKGROUND

• Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.

  PMID: 28105598 BACKGROUND

• Anttila M, Penttila J, Helminen A, Vuorilehto L, Scheinin H. Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3. doi: 10.1046/j.1365-2125.2003.01944.x.

  PMID: 14616431 BACKGROUND

• Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.

  PMID: 18363626 BACKGROUND

• Lin L, Guo X, Zhang MZ, Qu CJ, Sun Y, Bai J. Pharmacokinetics of dexmedetomidine in Chinese post-surgical intensive care unit patients. Acta Anaesthesiol Scand. 2011 Mar;55(3):359-67. doi: 10.1111/j.1399-6576.2010.02392.x.

  PMID: 21288220 BACKGROUND

• Iirola T, Ihmsen H, Laitio R, Kentala E, Aantaa R, Kurvinen JP, Scheinin M, Schwilden H, Schuttler J, Olkkola KT. Population pharmacokinetics of dexmedetomidine during long-term sedation in intensive care patients. Br J Anaesth. 2012 Mar;108(3):460-8. doi: 10.1093/bja/aer441. Epub 2012 Jan 25.

  PMID: 22277665 BACKGROUND

• Lee S, Kim BH, Lim K, Stalker D, Wisemandle W, Shin SG, Jang IJ, Yu KS. Pharmacokinetics and pharmacodynamics of intravenous dexmedetomidine in healthy Korean subjects. J Clin Pharm Ther. 2012 Dec;37(6):698-703. doi: 10.1111/j.1365-2710.2012.01357.x. Epub 2012 May 31.

  PMID: 22650799 BACKGROUND

• Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740.

  PMID: 26068206 BACKGROUND

• Potts AL, Anderson BJ, Warman GR, Lerman J, Diaz SM, Vilo S. Dexmedetomidine pharmacokinetics in pediatric intensive care--a pooled analysis. Paediatr Anaesth. 2009 Nov;19(11):1119-29. doi: 10.1111/j.1460-9592.2009.03133.x. Epub 2009 Aug 25.

  PMID: 19708909 BACKGROUND

• Chamadia S, Pedemonte JC, Hobbs LE, Deng H, Nguyen S, Cortinez LI, Akeju O. A Pharmacokinetic and Pharmacodynamic Study of Oral Dexmedetomidine. Anesthesiology. 2020 Dec 1;133(6):1223-1233. doi: 10.1097/ALN.0000000000003568.

  PMID: 32986820 BACKGROUND

• Dashiff CJ, Weaver M. Development and testing of a scale to measure separation anxiety of parents of adolescents. J Nurs Meas. 2008;16(1):61-80. doi: 10.1891/1061-3749.16.1.61.

  PMID: 18578110 BACKGROUND

• Keles S, Kocaturk O. Comparison of oral dexmedetomidine and midazolam for premedication and emergence delirium in children after dental procedures under general anesthesia: a retrospective study. Drug Des Devel Ther. 2018 Mar 28;12:647-653. doi: 10.2147/DDDT.S163828. eCollection 2018.

  PMID: 29636599 BACKGROUND

• Weldon BC, Watcha MF, White PF. Oral midazolam in children: effect of time and adjunctive therapy. Anesth Analg. 1992 Jul;75(1):51-5. doi: 10.1213/00000539-199207000-00010.

  PMID: 1616162 BACKGROUND

• Shukry M, Clyde MC, Kalarickal PL, Ramadhyani U. Does dexmedetomidine prevent emergence delirium in children after sevoflurane-based general anesthesia? Paediatr Anaesth. 2005 Dec;15(12):1098-104. doi: 10.1111/j.1460-9592.2005.01660.x.

  PMID: 16324031 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Anesthesia, General; Control Groups

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Soroush Merchant, MD, MS

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soroush Merchant, MD, MS

CONTACT

816-3018595; smerchant@cmh.edu

Kelsye Howell, MSN, RN

CONTACT

816-760-5919; klhowell@cmh.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Medical Pain Service, Principal Investigator, Assistant Professor of Anesthesiology, MD, MS

Model Details: Prospective Pilot Study, Single-site, open-label, phase I dose escalation trial

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: November 17, 2022
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication

Locations

US (1)