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Completed

NCT Number: NCT01795222

Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

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

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Key information

Conditions

Early Childhood Caries Behavior Behavioral Symptoms Child Behavior Stress, Psychological

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Federal University of Goias

Goiânia, Goiás, 74605220, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

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

Drug

Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam

Other names: Magistral formula

Primary outcomes

  1. 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

    level of salivary cortisol according to the ELISA

Secondary outcomes

  1. Child behaviour

    Time frame: 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)

  2. sedative safety

    Time frame: during and twenty four hours after the procedure

    assessed according to the World SIVA adverse sedation event reporting tool

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Collaborators

  • Federal University of Minas Gerais

Registry information

Official study title

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

Acronym: Pedsed-I

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 20, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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