Oral Dexmedetomidine in Pediatric MRI

Official title

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

Overview

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

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.

Interventions

• Drug Dexmedetomidine
  Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI
• Drug General Anesthesia (control group)
  Participants will receive general anesthesia for their MRI

Primary outcome measures

• 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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
• Inability to have MRI scans
• Non-English speaking volunteers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Children's Mercy Hospital — Kansas City

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05619627 · STUDY00002526

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗