MRIPhase 3NCT05192629
Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
A Phase 3 study testing Dexmedetomidine and Midazolam in people with MRI and Pediatric Sedation, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- MRI, Pediatric Sedation, Midazolam
- What is being tested?
- Dexmedetomidine and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Mar 2022to 31 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.),
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020
Denis Schmartz, MD, +3224773996, denis.schmartz@chu-brugmann.be
About this study
Official title: 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.
Read more
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.
- Conditions
- MRI, Pediatric Sedation, Midazolam, Dexmedetomidine
- Being tested
- Dexmedetomidine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Premedication by intranasal dexmedetomidine
MidazolamDrug
Premedication by intranasal midazolam
| Study group | Role | What they receive |
|---|---|---|
| Group Midazolam | Active comparator | 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). Receives: Drug: Midazolam |
| Group Dexmedetomidine | Experimental | 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). Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bradycardia
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
Measured: 6 hours
Hypotension
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
Measured: 6 hours
Desaturation
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
Measured: 6 hours
Movements
Incidence of involuntary movements requiring intervention by the anesthesiologist in charge of the patient to deepen sedation; expressed as percentage of patients
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start9 Mar 2022
- Primary completion15 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for MRIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis SCHMARTZ, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192629
- Sponsor's protocol ID
- CHUB-PED-MIDEX_MRI
- Status last verified
- Mar 2022
- First submitted
- 28 Dec 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
PubMed 27354454Gutmann A, Pessenbacher K, Gschanes A, Eggenreich U, Wargenau M, Toller W. Propofol anesthesia in spontaneously breathing children undergoing magnetic resonance imaging: comparison of two propofol emulsions. Paediatr Anaesth. 2006 Mar;16(3):266-74. doi: 10.1111/j.1460-9592.2005.01777.x.
PubMed 16490090Jung SM. Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging. Yeungnam Univ J Med. 2020 Jul;37(3):159-168. doi: 10.12701/yujm.2020.00171. Epub 2020 Apr 17.
PubMed 32299181Yip P, Middleton P, Cyna AM, Carlyle AV. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006447. doi: 10.1002/14651858.CD006447.pub2.
PubMed 19588390Ghai B, Jain K, Saxena AK, Bhatia N, Sodhi KS. Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr Anaesth. 2017 Jan;27(1):37-44. doi: 10.1111/pan.13010. Epub 2016 Oct 13.
PubMed 27734549Chorney JM, Kain ZN. Behavioral analysis of children's response to induction of anesthesia. Anesth Analg. 2009 Nov;109(5):1434-40. doi: 10.1213/ane.0b013e3181b412cf. Epub 2009 Aug 27.
PubMed 19713262Leroy PL, Costa LR, Emmanouil D, van Beukering A, Franck LS. Beyond the drugs: nonpharmacologic strategies to optimize procedural care in children. Curr Opin Anaesthesiol. 2016 Mar;29 Suppl 1:S1-13. doi: 10.1097/ACO.0000000000000312.
PubMed 26926330Sadeghi A, Khaleghnejad Tabari A, Mahdavi A, Salarian S, Razavi SS. Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents: a randomized clinical trial. Neuropsychiatr Dis Treat. 2017 Feb 20;12:3237-3241. doi: 10.2147/NDT.S119208. eCollection 2017.
PubMed 28260897Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F. Predictors of preoperative anxiety in children. Anaesth Intensive Care. 2003 Feb;31(1):69-74. doi: 10.1177/0310057X0303100114.
PubMed 12635399Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
PubMed 28639236Sun Y, Lu Y, Huang Y, Jiang H. Is dexmedetomidine superior to midazolam as a premedication in children? A meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Aug;24(8):863-74. doi: 10.1111/pan.12391. Epub 2014 Mar 26.
PubMed 24666837Talon MD, Woodson LC, Sherwood ER, Aarsland A, McRae L, Benham T. Intranasal dexmedetomidine premedication is comparable with midazolam in burn children undergoing reconstructive surgery. J Burn Care Res. 2009 Jul-Aug;30(4):599-605. doi: 10.1097/BCR.0b013e3181abff90.
PubMed 19506498Radhika KP, Sreejit MS, Ramadas KT. Efficacy of midazolam as oral premedication in children in comparison to triclofos sodium. Indian J Anaesth. 2016 Jun;60(6):415-9. doi: 10.4103/0019-5049.183389.
PubMed 27330204Mahmoud M, Barbi E, Mason KP. Dexmedetomidine: What's New for Pediatrics? A Narrative Review. J Clin Med. 2020 Aug 24;9(9):2724. doi: 10.3390/jcm9092724.
PubMed 32846947Petroz GC, Sikich N, James M, van Dyk H, Shafer SL, Schily M, Lerman J. A phase I, two-center study of the pharmacokinetics and pharmacodynamics of dexmedetomidine in children. Anesthesiology. 2006 Dec;105(6):1098-110. doi: 10.1097/00000542-200612000-00009.
PubMed 17122572
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05192629
- Acronym / sponsor ID
- CHUB-PED-MIDEX_MRI
- Conditions
- MRI, Pediatric Sedation, Midazolam, Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Midazolam | Active comparator | Drug: MidazolamAdministration 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). |
| Group Dexmedetomidine | Experimental | Drug: DexmedetomidineAdministration 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). |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePremedication by intranasal dexmedetomidine | Drug | Group Dexmedetomidine |
| MidazolamPremedication by intranasal midazolam | Drug | Group Midazolam |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 27354454Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
- Background: PubMed 16490090Gutmann A, Pessenbacher K, Gschanes A, Eggenreich U, Wargenau M, Toller W. Propofol anesthesia in spontaneously breathing children undergoing magnetic resonance imaging: comparison of two propofol emulsions. Paediatr Anaesth. 2006 Mar;16(3):266-74. doi: 10.1111/j.1460-9592.2005.01777.x.
- Background: PubMed 32299181Jung SM. Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging. Yeungnam Univ J Med. 2020 Jul;37(3):159-168. doi: 10.12701/yujm.2020.00171. Epub 2020 Apr 17.
- Background: PubMed 19588390Yip P, Middleton P, Cyna AM, Carlyle AV. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006447. doi: 10.1002/14651858.CD006447.pub2.
- Background: PubMed 27734549Ghai B, Jain K, Saxena AK, Bhatia N, Sodhi KS. Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr Anaesth. 2017 Jan;27(1):37-44. doi: 10.1111/pan.13010. Epub 2016 Oct 13.
- Background: PubMed 19713262Chorney JM, Kain ZN. Behavioral analysis of children's response to induction of anesthesia. Anesth Analg. 2009 Nov;109(5):1434-40. doi: 10.1213/ane.0b013e3181b412cf. Epub 2009 Aug 27.
- Background: PubMed 26926330Leroy PL, Costa LR, Emmanouil D, van Beukering A, Franck LS. Beyond the drugs: nonpharmacologic strategies to optimize procedural care in children. Curr Opin Anaesthesiol. 2016 Mar;29 Suppl 1:S1-13. doi: 10.1097/ACO.0000000000000312.
- Background: PubMed 28260897Sadeghi A, Khaleghnejad Tabari A, Mahdavi A, Salarian S, Razavi SS. Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents: a randomized clinical trial. Neuropsychiatr Dis Treat. 2017 Feb 20;12:3237-3241. doi: 10.2147/NDT.S119208. eCollection 2017.
- Background: PubMed 12635399Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F. Predictors of preoperative anxiety in children. Anaesth Intensive Care. 2003 Feb;31(1):69-74. doi: 10.1177/0310057X0303100114.
- Background: PubMed 28639236Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
- Background: PubMed 24666837Sun Y, Lu Y, Huang Y, Jiang H. Is dexmedetomidine superior to midazolam as a premedication in children? A meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Aug;24(8):863-74. doi: 10.1111/pan.12391. Epub 2014 Mar 26.
- Background: PubMed 19506498Talon MD, Woodson LC, Sherwood ER, Aarsland A, McRae L, Benham T. Intranasal dexmedetomidine premedication is comparable with midazolam in burn children undergoing reconstructive surgery. J Burn Care Res. 2009 Jul-Aug;30(4):599-605. doi: 10.1097/BCR.0b013e3181abff90.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Midazolam in people with MRI and Pediatric Sedation, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis Schmartz, MD (+3224773996, denis.schmartz@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bradycardia (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192629, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.