Oral Dexmedetomidine in Pediatric MRI

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05619627
• Other study ID #: STUDY00002526
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Soroush Merchant, MD, MS
• Phone: 816-3018595
• Email: smerchant[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 one of the most dominant imaging modalities 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, imaging tests such as MRI scans are highly susceptible to motion artifact and require a state of immobility that may not be obtainable in awake uncooperative patients such as pediatrics. 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 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 an awake IV access could be very traumatizing and leave 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 6 Years

Eligibility

Inclusion Criteria:

1. Subjects ages 4 months to 6 years

2. Undergoing a clinically indicated MRI with anesthesia

Exclusion Criteria:

1. Refusal to take oral dexmedetomidine

2. Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI

3. Known allergy to dexmedetomidine

4. Medical contraindication to administration of dexmedetomidine

• Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction

• Current use of digoxin

• Moya Moya disease

• New onset stroke

5. American Society of Anesthesiologists (ASA) physical status classification system > II

6. Contraindications to administering sedation

• 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 anomaly

7. Unable to have MRI

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmedetomidine
Patients will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
• General anesthetic
Patients will receive inhalational anesthetic to provide general anesthesia for undergoing MRI

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI motion artifact	The primary outcome is qualitative evaluation of MRI motion artifact. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic)	Immediately after the MRI scan completion
Secondary	Ramsay Sedation Score (RSS) of 4	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