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

Universidade Federal de Goias

Status and phase: Completed; Phase 4

Conditions: Early Childhood Caries

Treatments: Drug: Placebo; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01795222

307/2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Oral Midazolam

Active Comparator group

Description:

Midazolam oral syrup 1mg/Kg twenty minutes before starting the procedure

Treatment:

Drug: Midazolam

placebo

Placebo Comparator group

Description:

placebo oral syrup twenty minutes before starting the procedure

Treatment:

Drug: Placebo