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Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment (Pedsed-I)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 20, 2013
Last Update Posted: December 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Federal University of Minas Gerais
Information provided by (Responsible Party):
Heloisa de Sousa Gomes, Universidade Federal de Goias
Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment

Condition Intervention Phase
Early Childhood Caries Drug: Midazolam Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo

Resource links provided by NLM:

Further study details as provided by Heloisa de Sousa Gomes, Universidade Federal de Goias:

Primary Outcome Measures:
  • child stress [ Time Frame: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion ]
    level of salivary cortisol according to the ELISA

Secondary Outcome Measures:
  • Child behaviour [ Time Frame: every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes ]
    child dental treatment is video recorded and then a masked observer watches the videos and categorize child behavior according to the Ohio State University Behavioral Rating Scale (OSUBRS)

  • sedative safety [ Time Frame: during and twenty four hours after the procedure ]
    assessed according to the World SIVA adverse sedation event reporting tool

Enrollment: 18
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Midazolam
Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure
Drug: Midazolam
Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
Other Name: Brand: Dormire (Cristalia, Sao Paulo, Brazil)
Placebo Comparator: placebo
placebo oral syrup twenty minutes before starting the procedure
Drug: Placebo
Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam
Other Name: Magistral formula

Detailed Description:

This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:

  • oral midazolam + oral ketamine + inhaled sevoflurane
  • oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.

However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.

We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.


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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries

Exclusion Criteria:

  • Children presenting with at least one of the following:
  • airway obstruction and/or oral breathing;
  • recent use of systemic corticosteroids
  • needing less than two dental restorations;
  • previous dental sedation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795222

Faculty of Dentistry, Federal University of Goias
Goiânia, Goias, Brazil, 74605220
Sponsors and Collaborators
Universidade Federal de Goias
Federal University of Minas Gerais
Principal Investigator: Heloisa S Gomes, DDS Universidade Federal de Goias
Study Director: Aline C Batista, PhD Universidade Federal de Goias
  More Information

Responsible Party: Heloisa de Sousa Gomes, Principal Investigator, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT01795222     History of Changes
Other Study ID Numbers: 307/2011
First Submitted: December 19, 2012
First Posted: February 20, 2013
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Heloisa de Sousa Gomes, Universidade Federal de Goias:
conscious sedation
stress psychological
dental care for children
child behavior

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action