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

A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo

Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment

Study Overview

• Status: Completed
• Conditions: Early Childhood Caries
• Intervention / Treatment: Drug: Midazolam; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Goias
    • Goiânia, Goias, Brazil, 74605220
      • Faculty of Dentistry, Federal University of Goias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Magistral formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child stress	level of salivary cortisol according to the ELISA	At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child behaviour	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)	every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes
sedative safety	assessed according to the World SIVA adverse sedation event reporting tool	during and twenty four hours after the procedure

Collaborators and Investigators

• Sponsor: Universidade Federal de Goias
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: February 17, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: child behavior; saliva; conscious sedation; dental care for children; stress psychological
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 307/2011