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

This study has been completed.
Sponsor:
Collaborator:
Federal University of Minas Gerais
Information provided by (Responsible Party):
Heloisa de Sousa Gomes, Universidade Federal de Goias
ClinicalTrials.gov Identifier:
NCT01795222
First received: December 19, 2012
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795222

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

No publications provided

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
Study First Received: December 19, 2012
Last Updated: December 2, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Goias:
conscious sedation
stress psychological
dental care for children
child behavior
saliva

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

ClinicalTrials.gov processed this record on September 30, 2014