Trial reportPloS one2019
Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02447289 (Efficacy, Safety and Cost-effectiveness of Intranasal Sedation With Ketamine and Midazolam in Pediatric Dentistry), which is not on this map. Cited by 25 papers, 4 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.
Efficacy, Safety and Cost-effectiveness of Intranasal Sedation With Ketamine and Midazolam in Pediatric Dentistry: a Randomized Clinical Trial
Who cites it
25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Intranasal versus sublingual sedation in pediatric dentistry: a systematic review.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2026Pooled it
- 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
- Effect of Dexmedetomidine with or without Midazolam during procedural dental sedation in children: a randomized controlled clinical trial.BMC oral health · 2024Trial
- [Sedative effect of intranasal midazolam in neonates undergoing magnetic resonance imaging: a prospective single-blind randomized controlled study].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2020Trial
- Comparison between oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in autism spectrum disorder: double-blind randomized clinical trial.Brazilian journal of anesthesiology (Elsevier)Trial
- Comparative evaluation of ease in dental treatment using midazolam versus midazolam-ketamine in uncooperative children.Bioinformation · 2026Article
- Efficacy of intranasal sedation for pediatric dental procedures: a systematic review and meta-analysis.Journal of dental anesthesia and pain medicine · 2025Review
- Comparative Analysis of Preoperative Sedation Modalities: Oral Midazolam and Ketamine Versus Chloral Hydrate and Meperidine in Pediatric Tonsillectomy - A Randomized Clinical Trial.Turkish archives of otorhinolaryngology · 2025Article
- A Comparative Evaluation of Midazolam, Ketamine and Their Combination as Sedative Agents in Pediatric Dentistry: A Systematic Review and Meta-analysis.Frontiers in dentistry · 2025Review
- Analgosedation in Pediatric Emergency Care: A Comprehensive Scoping Review.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Fundamentals of Nonparametric Statistical Tests for Dental Clinical Research.Dentistry journal · 2024Review
- Comparative evaluation of intranasal midazolam-ketamine, dexmedetomidine-ketamine, midazolam-fentanyl, and dexmedetomidine-fentanyl combinations for procedural sedation and analgesia in pediatric dental patients: a randomized controlled trial.Journal of dental anesthesia and pain medicine · 2023Article
- Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review.Children (Basel, Switzerland) · 2022Review
- Post-Discharge Effects and Parents' Opinions of Intranasal Fentanyl with Oral Midazolam Sedation in Pediatric Dental Patients: A Cross-Sectional Study.Children (Basel, Switzerland) · 2022Article
- Success rate of nitrous oxide-oxygen procedural sedation in dental patients: systematic review and meta-analysis.Journal of dental anesthesia and pain medicine · 2021Review
- Amnesia after Midazolam and Ketamine Sedation in Children: A Secondary Analysis of a Randomized Controlled Trial.Journal of clinical medicine · 2021Article
- Oral sedation in dentistry: evaluation of professional practice of oral hydroxyzine in the University Hospital of Rennes, France.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2021Article
- Intranasal Dexmedetomidine Compared to a Combination of Intranasal Dexmedetomidine with Ketamine for Sedation of Children Requiring Dental Treatment: A Randomized Clinical Trial.Journal of clinical medicine · 2021Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe optimal sedative regime that provides the greatest comfort and the lowest risk for procedural sedation in young children remains to be determined. The aim of this randomized, blinded, controlled, parallel-design trial was to evaluate the efficacy of intranasal ketamine and midazolam as the main component of the behavioral guidance approach for preschoolers during dental treatment. MATERIALS AND
methodsChildren under seven years of age, with caries and non-cooperative behavior, were randomized into three groups: (KMIN) intranasal ketamine and midazolam; (KMO) oral ketamine and midazolam; or (MO) oral midazolam. The dental sedation appointments were videotaped, and the videos were analyzed using the Ohio State University Behavioral Rating Scale (OSUBRS) to determine the success of the sedation in each group. Intra- and postoperative adverse events were recorded. Data analysis involved descriptive statistics and non-parametric tests (P < 0.05, IBM SPSS).
resultsParticipants were 84 children (28 per group; 43 boys), with a mean age of 3.1 years (SD 1.2). Children's baseline and the dental sedation session characteristics were balanced among groups. The success of the treatment as assessed by the dichotomous variable 'quiet behavior for at least 60% of the session length' was: KMIN 50.0% (n = 14; OR 2.10, 95% CI 0.71 to 6.30), KMO 46.4% (n = 13; OR 1.80, 95% CI 0.62 to 5.40), MO 32.1% (n = 9) (P = 0.360). Adverse events were minor, occurred in 37 of 84 children (44.0%), and did not differ among groups (P = 0.462).
conclusionAll three regimens provided moderate dental sedation with minor adverse events, with marked variability in the behavior of children during dental treatment. The potential benefit of the ketamine-midazolam combination should be further investigated in studies with larger samples.
trial registrationClinicalTrials.gov, identifier: NCT02447289. Registered on 11 May 2015, named "Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment (NASO)."
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