Efficacy of Moderate Sedation for Dental Treatment of Young Children

Phase 4 Completed 41 enrolled Federal University of Goiás Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

There is lack of clinical trials on pediatric dental sedation. The purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. A further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.

Timeline

Start: 2008-06
Primary completion: 2010-12
Completion: 2012-05

Publications

Results Moreira TA, Costa PS, Costa LR, Jesus-Franca CM, Antunes DE, Gomes HS, Neto OA. Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial. Int J Paediatr Dent. 2013 May;23(3):207-15. doi: 10.1111/j.1365-263X.2012.01246.x. Epub 2012 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	3 mg/kg	Oral
Comparator	Midazolam	Small molecule	0.5 mg/kg	Oral
Comparator	Midazolam	Small molecule	1 mg/kg	Oral

Efficacy of Moderate Sedation for Dental Treatment of Young Children

Summary

Timeline

Publications

Drugs

Indications