Dexmedetomidine Sedation in Children Before MRI Examinations

NCT05163704 | Completed

• 1 other identifier: MR-Dexdor
• Study Type: interventional
• Target: 1,091
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine, has been used in the past 4-5 years as an alternative sedation method for children at the pediatric radiology department in order to reduce the waiting lists and the use of general anesthesia with its risks and side effects in magnetic resonance and computed tomography examinations.

Conditions

Deep Sedation

Outcome Measures

Primary Outcomes (3)

• Changes in oxygen desaturation using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination

  During the scan the following important safety issue was followed: oxygen desaturation (SpO2 \< 95 %) monitored by pulse oximetry. Low SpO2 was defined as a level below the mean value for age. If the SpO2 dropped below these levels, appropriate actions were taken (i.e., contact anesthesiologist). Since no fasting restrictions is part of the Dexmedetomidine-MRI protocol, specific attention was paid to the potential occurrence of regurgitation of stomach contents and/or aspiration during the entire sedation period. Pre- and post-sedation SpO2 (recorded in the radiology clinic pre- vs. post-scan) was compared to identify any negative effects on HR and NIBP during the early post-scan phase.

  Pre-sedation, during examination and post-sedation up to 24 weeks

• Changes in heart rate using Dexmedetomidine to replace general anesthesia prior to magnetic resonance imaging examination

  During the scan the following important safety issue was followed: heart rate, monitored by pulse oximetry. Low heart rate was defined as a level below the mean value for age. If the heart rate dropped below these levels, appropriate actions were taken (i.e., contact anesthesiologist). Pre- and post-sedation heart rate (recorded in the radiology clinic pre- vs. post-scan) were compared to identify any negative effects on SpO2 and NIBP during the early post-scan phase.

  Pre-sedation, during examination and post-sedation up to 24 weeks

• Changes in non-invasive blood preassure using Dexmedetomidine to replace general Changes in NIBP using Dexmedetomidine to replace anesthesia prior to magnetic resonance imaging examination

  During the scan the following important safety issue was followed: NIBP monitored. Low or high systolic and/or dyastolic blood preassure was defined according the mean value for age. If any of parameters changed below/above the normal levels for age, appropriate actions were taken (i.e., contact anesthesiologist). Pre- and post-sedation NIBP (recorded in the radiology clinic pre- vs. post-scan) were compared to identify any negative effects on HR and SpO2 during the early post-scan phase.

  Pre-sedation, during examination and post-sedation up to 24 weeks

Secondary Outcomes (1)

• Assessment of image quality using Dexmedetomidine as a sedative for children undergoing MRI examination

  After sedation through study completion, an average of 1.5 years

Study Arms (1)

MRI Dexmedetomidine sedation

OTHER

Drug used: Dexmedetomidine. Given in increments of 0.2 ml at the time with atomizer (MAD Nasal™, Wayne Pennsylvania). Administered by radiology staff. Dose 1 of nasal dexmedetomidine: 4 mcg/kg max 200 mcg Dose 2 of nasal dexmedetomidine: 2 mcg/kg max 100 mcg

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine is a beneficial sedative for children. It provides a sedation equivalent to a natural deep sleep with negligible respiratory effects. Administration via the nose provides better absorption and faster impact effect. The drug does not taste and does not sting when administered.

Also known as: Intranasal spray

MRI Dexmedetomidine sedation

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children, according to the American Society of Anesthesiologists (ASA) risk classification. Children with ASA risk class 1 or 2 were selected by the anesthesiologist as suitable for radiographer handled sedation with Dexmedetomidine.

You may not qualify if:

• Children with significant comorbidity (ASA risk class 3 or 4) that were deemed to need presence of an anesthesia team (anesthesiologist plus certified anesthesia nurse) for safety reasons.
• Children that due to the specific nature of the MRI scan would need a general anesthetic to provide a secure airway (e.g., laryngeal mask airway or endotracheal intubation) during the scan (e.g., mild neck manipulation to assess cervical instability in Mb Down patients, multiple different MRI investigations requested or need for apnea).
• Children that present minimal cold symptoms the day of imaging.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (6)

• Pansini V, Curatola A, Gatto A, Lazzareschi I, Ruggiero A, Chiaretti A. Intranasal drugs for analgesia and sedation in children admitted to pediatric emergency department: a narrative review. Ann Transl Med. 2021 Jan;9(2):189. doi: 10.21037/atm-20-5177.

  PMID: 33569491 RESULT

• Zhang Y, Zhang R, Meng HY, Wang MX, Du SZ. [Efficacy and safety of intranasal dexmedetomidine premedication for children undergoing CT or magnetic resonance imaging: a systematic review and meta-analysis]. Zhonghua Er Ke Za Zhi. 2020 Apr 2;58(4):314-318. doi: 10.3760/cma.j.cn112140-20191224-00830. Chinese.

  PMID: 32234139 RESULT

• Li L, Zhou J, Yu D, Hao X, Xie Y, Zhu T. Intranasal dexmedetomidine versus oral chloral hydrate for diagnostic procedures sedation in infants and toddlers: A systematic review and meta-analysis. Medicine (Baltimore). 2020 Feb;99(9):e19001. doi: 10.1097/MD.0000000000019001.

  PMID: 32118711 RESULT

• Mondardini MC, Amigoni A, Cortellazzi P, Di Palma A, Navarra C, Picardo SG, Puzzutiello R, Rinaldi L, Vitale F, Zito Marinosci G, Conti G. Intranasal dexmedetomidine in pediatrics: update of current knowledge. Minerva Anestesiol. 2019 Dec;85(12):1334-1345. doi: 10.23736/S0375-9393.19.13820-5. Epub 2019 Oct 14.

  PMID: 31630510 RESULT

• Uusalo P, Guillaume S, Siren S, Manner T, Vilo S, Scheinin M, Saari TI. Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients. Anesth Analg. 2020 Apr;130(4):949-957. doi: 10.1213/ANE.0000000000004264.

  PMID: 31206433 RESULT

• Karlsson J, Lewis G, Larsson P, Lonnqvist PA, Diaz S. Intranasal dexmedetomidine sedation for paediatric MRI by radiology personnel: A retrospective observational study. Eur J Anaesthesiol. 2023 Mar 1;40(3):208-215. doi: 10.1097/EJA.0000000000001786. Epub 2022 Dec 22.

  PMID: 36546479 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joakim Dillner, MD PhD

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 20, 2021
• Study Start: November 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2022
• Access Criteria: Protocol with doses and way of administration will shares with radiology and anesthesiology departments who wants to implement the method. Contact could be establish by e-post and local visit for demonstration will be available. Contact with the Central contact person and the Central contact back-up could be made.

Locations

SE (1)