Trial reportBMC anesthesiology2023
Oral midazolam vs. intranasal dexmedetomidine plus oral midazolam for sedation of pediatric outpatients: a double-blinded randomized controlled trial.
Trial report in BMC anesthesiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Intranasal dexmedetomidine versus midazolam for pediatric dental sedation: a pooled analysis of clinical trials.Frontiers in medicine · 2026Pooled it
- Drugs for Procedural Sedation and Analgesia in Children: A Systematic Review and Meta-analysis.Drugs in R&D · 2025Pooled it
- Efficacy of Midazolam in Outpatient Pediatric Dentistry: A Systematic Review.Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric DentistryPooled it
- Application of oral midazolam for preoperative sedation in pediatric tonsillectomy and adenoidectomy and its effects on emergence delirium.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026Trial
- Intranasal Dexmedetomidine with Propofol Provides Superior Sedation for Pediatric Contrast-Enhanced CT: A Randomized Controlled Trial.Drug design, development and therapy · 2025Trial
- Combined sedation in pediatric magnetic resonance imaging: determination of median effective dose of intranasal dexmedetomidine combined with oral midazolam.BMC anesthesiology · 2024Trial
- Impact of midazolam on salivary glands: a comprehensive analysis of oxidative biochemistry, morphological changes, and salivary composition.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Recovery Time, Patient Satisfaction, and Safety of Intranasal Sedatives in Pediatric Dentistry: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2025Review
- Comparative evaluation of the effectiveness and acceptance of intranasal dexmedetomidine and intranasal midazolam for sedation in children aged 5-8 years using a mucosal atomizer device: a randomized controlled clinical study.Journal of dental anesthesia and pain medicine · 2025Article
- Efficacy of intranasal sedation for pediatric dental procedures: a systematic review and meta-analysis.Journal of dental anesthesia and pain medicine · 2025Review
- Effective dose of intranasal remimazolam for preoperative sedation in preschool children: a dose-finding study using Dixon's up-and-down method.Frontiers in pharmacology · 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
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundModerate to deep sedation is required for dental treatment of children with dental anxiety. Midazolam is the most commonly used sedative, whereas intranasal dexmedetomidine is increasingly used in pediatric sedation.
objectiveThe aim of this trial was to compare the sedative efficacy of oral midazolam alone with that of intranasal dexmedetomidine plus oral midazolam during dental treatment of children with dental anxiety.
designIn total, 83 children (aged 3-12 years) scheduled to undergo dental sedation were randomized to receive oral midazolam (0.5 mg/kg) and intranasal placebo, or oral midazolam (0.5 mg/kg) plus intranasal dexmedetomidine (2 µg/kg). The primary outcome was the rate of successful sedation for dental treatment. Secondary outcomes were the onset time and adverse events during and after treatment. Data analyses involved descriptive statistics and nonparametric tests.
resultsThe rate of successful sedation was significantly higher in combination group (P = 0.007), although the sedation onset time was significantly longer in combination group (17.5 ± 2.4 min) than in monotherapy group (15.7 ± 1.8) (P = 0.003). No children required medical intervention or oxygen therapy for hemodynamic disturbances, and the incidences of adverse events had no significant difference between groups (P = 0.660).
conclusionCombined treatment with oral midazolam (0.5 mg/kg) and intranasal dexmedetomidine (2 µg/kg) is more significantly effective for managing the behavior of non-cooperative children during dental treatment, compared to oral midazolam (0.5 mg/kg) alone. (Chinese Clinical Trial Registry: ChiCTR2100042300)
trial registrationChiCTR2100042300, Clinical trial first registration date: 17/01/2021.
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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.