Pedsed-I: Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Sponsor

Universidade Federal de Goias (Other)

Overall Status

Completed

CT.gov ID

NCT01795222

Collaborator

Federal University of Minas Gerais (Other)

Enrollment

Location

Arms

11.1

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Early Childhood Caries	Drug: Midazolam Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

child stress [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 [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 [during and twenty four hours after the procedure]
assessed according to the World SIVA adverse sedation event reporting tool

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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