Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Early Childhood Caries Clinical Trial

— Pedsed-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795222
• Other study ID #: 307/2011
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: December 2, 2013
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: December 2013
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• Midazolam
Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
• Placebo
Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam

Locations

Country	Name	City	State
Brazil	Faculty of Dentistry, Federal University of Goias	Goiânia	Goias

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	sedative safety	assessed according to the World SIVA adverse sedation event reporting tool	during and twenty four hours after the procedure	Yes