drugset / Trial / NCT02447289
Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment
Phase 4
Completed
84 enrolled
Federal University of Goiás
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.
Timeline
- Start
- 2015-05-21
- Primary completion
- 2016-10-11
- Completion
- 2016-10-18
Publications
- Sado-Filho J, Viana KA, Correa-Faria P, Costa LR, Costa PS. Randomized clinical trial on the efficacy of intranasal or oral ketamine-midazolam combinations compared to oral midazolam for outpatient pediatric sedation. PLoS One. 2019 Mar 11;14(3):e0213074. doi: 10.1371/journal.pone.0213074. eCollection 2019.
- Gomes HS, Miranda AR, Viana KA, Batista AC, Costa PS, Daher A, Machado GC, Sado-Filho J, Vieira LA, Correa-Faria P, Hosey MT, Costa LR. Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):172. doi: 10.1186/s13063-017-1919-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 4 mg/kg | Intranasal |
| Subject | Midazolam | Small molecule | 0.2 mg/kg | Intranasal |
| Subject | Midazolam | Small molecule | 0.5 mg/kg | Intranasal |
| Subject | Midazolam | Small molecule | 1 mg/kg | Intranasal |