UnknownPhase 3

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

Belgium250 participantsStarted 2022-03-09

Plain-language summary

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.

Who can participate

Age range

6 Months – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of bradycardia

Timeframe: 6 hours

Hypotension

Timeframe: 6 hours

Desaturation

Timeframe: 6 hours

Movements

Timeframe: 6 hours

Trial details

NCT IDNCT05192629

SponsorBrugmann University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-15

Contact for this trial

Denis Schmartz, MD

+3224773996 denis.schmartz@huderf.be

View on ClinicalTrials.gov More MRI trials

Plain-language summary

Who can participate

Age range

6 Months – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.