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NCT02447289: NASO
Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment
Phase 4 trial testing Intranasal ketamine in Child Behavior in 84 participants. Completed in 18 October 2016.
11 October 2016
Quick facts
| Lead sponsor | Universidade Federal de Goias |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 21 May 2015 |
| Primary completion | 11 October 2016 |
| Estimated completion | 18 October 2016 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Intranasal ketamine — full drug profile →
- Oral ketamine — full drug profile →
- Intranasal midazolam — full drug profile →
- Oral midazolam
Conditions studied
- Child Behavior — all drugs for Child Behavior →
- Dental Caries — all drugs for Dental Caries →
Sponsor
Universidade Federal de Goias — full company profile →
Who can join
Adults 2 to 6, any sex, with Child Behavior or Dental Caries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation.
Sado-Filho J, Viana KA, Corrêa-Faria P, Costa LR, et al · · 2019 · cited 25× · PMID 30856181 · DOI 10.1371/journal.pone.0213074 -
Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial.
Gomes HS, Miranda AR, Viana KA, Batista AC, et al · · 2017 · cited 12× · PMID 28399933 · DOI 10.1186/s13063-017-1919-2 -
Amnesia after Midazolam and Ketamine Sedation in Children: A Secondary Analysis of a Randomized Controlled Trial.
Viana KA, Moterane MM, Green SM, Mason KP, et al · · 2021 · cited 1× · PMID 34830712 · DOI 10.3390/jcm10225430 -
Mother-child interactions and young child behavior during procedural conscious sedation.
Miranda-Remijo D, Orsini MR, Corrêa-Faria P, Costa LR. · · 2016 · cited 1× · PMID 27914480 · DOI 10.1186/s12887-016-0743-2
Verify or expand the search:
- PubMed search for NCT02447289
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05783492 — INK Feasibility Study · Phase 3 · withdrawn
- NCT04150757 — Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED · Phase 3 · terminated
Other recruiting trials for Child Behavior
Currently open trials in the same condition.
- NCT07209696 — Storybook and Animation Video Adjuncts to Tell-Show-Do in Pediatric Dentistry · NA · active not recruiting
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- NCT06341179 — Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep) · NA · recruiting
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Other Universidade Federal de Goias trials
Trials by the same sponsor.
- NCT06636006 — Aerobic Exercise Versus Digital Cognitive Behavioral Therapy for Insomnia · NA · recruiting
- NCT04605016 — Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces · NA · unknown
- NCT04760457 — Mandibular Overdentures Retained by Mini Implants: a Clinical Trial Comparing Different Surgical and Loading Protocols · NA · completed
- NCT06000280 — Evaluation of Retina in Patients With Glaucoma Using Topical Prostaglandins Undergoing Trabeculectomy Surgery · NA · completed
- NCT04691258 — Back Squat Exercise Treatment for Low Back Pain: Clinical Trial · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02447289 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade Federal de Goias
- Last refreshed: 30 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02447289.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing