Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging

March 9, 2022 updated by: Denis SCHMARTZ, Brugmann University Hospital

Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Phase 3 Clinical Trial Comparing the Safety and Efficacy of Intranasal Dexmedetomidine to Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging

A magnetic resonance imaging (MRI) examination usually takes 30 to 45 minutes and requires the patient to remain perfectly still during the entire acquisition process to ensure quality. Children under 6 years of age are not very cooperative and sedation is required for this age group.

Currently, there are no specific recommendations for sedation for a paediatric MRI examination. In 2018, a retrospective study on the sedation protocol applied at Hôpital Universitaire des Enfants Reine Fabiola (H.U.D.E.R.F.) was conducted. In this protocol, premedication was done with oral midazolam and sedation with iterative boluses of propofol. This study concluded that the protocol in place was effective, but found that image acquisition during the procedure was interrupted in 25% of cases, largely due to involuntary movements of the child.

Preoperative stress can be emotionally traumatic for the child and may even extend beyond the perioperative period, hence the importance of premedication. For the most anxious children, non-pharmacological means of premedication are often not sufficient. Moreover, the literature shows that pharmacological premedication is useful in reducing parental separation anxiety and in facilitating induction of anaesthesia.

Midazolam is an effective premedication agent with some disadvantages (paradoxical reaction, low compliance of oral intake). Dexmedetomidine is a highly effective α-2 receptor agonist that can also be used as premedication according to the current literature. A report by the Pediatric Sedation Research Consortium (P.S.R.C.) shows that it has a safe profile and an incidence rate of serious adverse events of 0.36% in the paediatric population. Furthermore, administered intranasally, it is non-invasive, painless and has good bioavailability (over 80%).

The primary objective is to demonstrate the superiority of intranasal dexmedetomidine over oral midazolam as a premedication for bolus sedation of propofol in terms of the incidence of any event during the MRI procedure requiring temporary or permanent interruption of the examination.

The impact of dexmedetomidine on the amount of propofol administered and on the post-sedation period, the impact of external factors on the primary objective, the acceptance of intranasal premedication by the children and the quality of the MRI images will also be analyzed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 3

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 Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Hopital Universitaire des Enfants Reine Fabiola

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

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of both sexes, aged 6 months to 6 years,
  • ASA score I to IV,
  • Requiring standard magnetic resonance imaging due to clinical condition, regardless of underlying pathology,
  • Sedation performed by an anesthesiologist,
  • Written informed consent in accordance with the ICH-GCP and local legislation prior to trial entry.

Exclusion Criteria:

  • Contraindications to MRI (cardiac pacemaker, neurostimulator, ferromagnetic implant),
  • Sedation carried out by a non-anesthesiologist,
  • Emergency MRI,
  • Presence of head trauma,
  • Presence of nasal congestion or upper respiratory tract infection on the day of sedation,
  • Multiple procedures during the same sedation (operating room, evoked potentials, etc.),
  • Children with pathologies requiring airway safety,
  • Any known allergic or hypersensitivity reaction to dexmedetomidine,
  • Any known allergic or hypersensitivity reaction to benzodiazepines,
  • Concomitant use of negative chronotropes, as Digoxine,
  • Patient known with chronic respiratory failure or myasthenia,
  • Patient known with anatomical abnormality of the airway, lung disease or sleep apnea syndrome
  • Patient with known cardiac rhythm abnormality or cardio-vascular disease,
  • Patient with known hepatic disorder or chronic kidney disease,
  • Patient with hypotension or bradycardia on the day of the examination,
  • Patient with a BMI > 97th percentile (which corresponds to overweight, including obesity).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Midazolam

Administration of oral midazolam (0.25 mg/kg) as premedication before propofol-based sedation.

The patient receives an oral premedication containing 0.125mL/kg of midazolam (which corresponds to a dosage of 0.25mg/kg of Ozalin® 2mg/ml, with a maximum of 20 mg). He/she also receives an intranasal spray containing matching placebo of dexmedetomidine (NaCl 0.9%). The volume administered corresponds to 0.02 mL/kg (which corresponds to a dosage of 2 mcg/kg of pure dexmedetomidine 100 mcg/mL in group D).
Drug: Midazolam
Premedication by intranasal midazolam
Experimental: Group Dexmedetomidine

Administration of intranasal dexmedetomidine as premedication before propofol-based sedation.

The patient receives an intranasal premedication containing 2 mcg/kg of dexmedetomidine. He/she also receives an oral solution containing matching placebo of midazolam (flavored-water prepared by the pharmacy). The volume administered corresponds to 0.125 mL/kg (which corresponds to a dosage of 0.25mg/kg of Ozalin® 2mg/mL, with a maximum of 20 mg or 10mL).
Drug: Dexmedetomidine
Premedication by intranasal dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bradycardia
Time Frame: 6 hours
Incidence of bradycardia (defined as a decrease of 2 standard deviations from normal for age, as described by the American Heart Association (AHA) in the Pediatric Advanced Life Support (PALS) manual, and which requires intervention by the anesthesiologist in charge of the patient to improve heart rate and cardiac output); expressed as percentage of patients
6 hours
Hypotension
Time Frame: 6 hours
Incidence of hypotension (defined as a systolic blood pressure below the 5th percentile for age, as described by the AHA in the PALS manual, and which requires intervention by the anesthesiologist in charge of the patient to improve blood pressure); expressed as percentage of patients
6 hours
Desaturation
Time Frame: 6 hours
Incidence of oxygen desaturation under 95% (defined as moderate if SpO2 is between 90 and 95%, severe if below 90%); expressed as percentage of patients
6 hours
Movements
Time Frame: 6 hours
Incidence of involuntary movements requiring intervention by the anesthesiologist in charge of the patient to deepen sedation; expressed as percentage of patients
6 hours

Collaborators and Investigators

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

Sponsor

Brugmann University Hospital

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 (Actual)

March 9, 2022

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-PED-MIDEX_MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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