Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment

January 21, 2020 updated by: Nourhan M.Aly

Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial

The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.

Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21512
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range 4-6 years
  • Frankl scale score 2.
  • ASA I or II physical status.
  • Dental intervention under local anesthesia not requiring more than 30 minutes.
  • No previous dental experience.
  • Parent/guardian"s written consent.

Exclusion Criteria:

  • Dental treatment indicated under general anesthesia.
  • Presence of facial deformities.
  • History of neurological or cognitive alterations.
  • Mouth breathers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Midazolam group (MDZ)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
Drug: Midazolam group (MDZ)
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
Experimental: Dexmedetomidine group (DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
Drug: Dexmedetomidine group (DEX)
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
Experimental: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.
Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facemask acceptance during drug delivery
Time Frame: during the sedation procedure
It will be evaluated according to Zanaty & Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
during the sedation procedure
Effect of sedation on children's future behavior
Time Frame: after one week in the follow-up session
Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
after one week in the follow-up session
The 'ease of treatment completion' sing separate five-point scales.
Time Frame: immediately after completion of the dental treatment procedures.
This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
immediately after completion of the dental treatment procedures.
Post-operative effects of the sedation
Time Frame: immediately after completion of the dental treatment procedures.
This will be assessed according to Modified Vernon et al.
immediately after completion of the dental treatment procedures.
Analgo-sedative effect of each drug
Time Frame: during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
Onset of Sedation from drug administration until the onset of satisfactory sedation
during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
Analgo-sedative effect of each drug
Time Frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20
during the sedation procedure (after drug administration until reaching satisfactory sedation)
Analgo-sedative effect of each drug
Time Frame: during local anesthesia injection to start the operative procedure
The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
during local anesthesia injection to start the operative procedure
Analgo-sedative effect of each drug
Time Frame: during the sedation procedure (from its onset till meeting discharge criteria)
The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
during the sedation procedure (from its onset till meeting discharge criteria)
Analgo-sedative effect of each drug.
Time Frame: during the sedation procedure (from its onset till meeting discharge criteria)
Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
during the sedation procedure (from its onset till meeting discharge criteria)
Amnesic effect of sedative agents.
Time Frame: immediately after completion of the dental treatment procedures.
Anterograde amnesia: will be assessed according to a modification of Bulach et al.
immediately after completion of the dental treatment procedures.
Hemodynamic response of sedative agents.
Time Frame: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.
during the sedation procedure (from its onset till meeting discharge criteria)
Hemodynamic response of sedative agents.
Time Frame: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Heart rate will be counted
during the sedation procedure (from its onset till meeting discharge criteria)
Hemodynamic response of sedative agents.
Time Frame: during the sedation procedure (from its onset till meeting discharge criteria)
Vital sign: Oxygen saturation will be monitored using an oximeter
during the sedation procedure (from its onset till meeting discharge criteria)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

Investigators

  • Principal Investigator: Amira A El-Khatib, MSc, Alexandria University
  • Study Director: Nadia A Wahba, PhD, Alexandria University
  • Study Director: Tamer AM Ghoneim, PhD, Faculty of Medicine, Alexandria Univerity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

December 22, 2019

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IORG0008839 (Other Identifier: International No: Alexandria University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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