Trial reportTrials2023
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: the MIDEX MRI trial.
Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05192629 (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), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Intranasal Dexmedetomidine with Propofol Provides Superior Sedation for Pediatric Contrast-Enhanced CT: A Randomized Controlled Trial.Drug design, development and therapy · 2025Trial
- Understanding three standard study designs for randomized controlled trials.Journal of anesthesia · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChildren under 6 years who need magnetic resonance imaging usually require sedation to obtain best quality images, but the optimal sedation protocol remains to be determined. In 2018, we showed a 22% interruption in image acquisition during magnetic resonance imaging when performing a propofol-based sedation using a bolus approach. As non-pharmacological premedication is often insufficient to reduce the anxiety of children related to parental separation, pharmacological premedication may be useful to facilitate the induction of anesthesia. In our institution, effective premedication is obtained oral intake of midazolam, though its administration relies on patients' compliance and could also lead to paradoxical reaction. Dexmedetomidine has a safe profile in the pediatric population and can therefore represent an interesting alternative. The primary objective of this trial is to demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in reducing the occurrence of any event requiring temporary or definitive interruption of the examination to allow anesthesiologist intervention in children undergoing magnetic resonance imaging under propofol sedation.
methodsIn this single-center, prospective, randomized, double-blind, double-dummy, active comparator-controlled, superiority trial, we planned to include 250 patients, aged 6 months to 6 years, undergoing a scheduled magnetic resonance imaging requiring the presence of an anesthesiologist. After informed consent, the patients will be randomized to receive either oral midazolam or intranasal dexmedetomidine as premedication. The data will be analyzed in intention to treat, using Kolmogorov-Smirnov Z, chi-square, Wilcoxon, and Mann-Whitney U tests. A P-value < 0.05 will be considered statistically significant. DISCUSSION: The MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period.
trial registrationClinicalTrial.gov NCT05192629 . Registered on 14 January 2022. Protocol version 2.1.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.