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

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ClinicalTrials.gov Identifier: NCT03827408
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Nourhan M.Aly, University of Alexandria

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Drug: Midazolam group (MDZ) Drug: Dexmedetomidine group (DEX) Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The researcher, statistician and participants will be blinded to the intervention group. Only the supervisor and the anesthesiologist will be aware of the allocation group. After data collection is completed, the randomization code will be broken to reveal the allocation group.
Primary Purpose: Other
Official Title: Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment: A Randomized Clinical Trial
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : December 22, 2019

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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.(




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827408


Locations
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Egypt
Faculty of Dentistry, Alexandria University
Alexandria, Egypt, 21512
Sponsors and Collaborators
Nourhan M.Aly
Alexandria University
Investigators
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Principal Investigator: Amira A El-Khatib, MSc Alexandria University
Study Director: Nadia A Wahba, PhD Alexandria University
Study Director: Karin ML Dowidar, PhD Alexandria University
Study Director: Tamer AM Ghoneim, PhD Faculty of Medicine, Alexandria Univerity
Additional Information:
Publications:

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Responsible Party: Nourhan M.Aly, Clinical Instructor, University of Alexandria
ClinicalTrials.gov Identifier: NCT03827408    
Other Study ID Numbers: IORG0008839
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nourhan M.Aly, University of Alexandria:
Nebulized Dexmedetomidine
Nebulized Midazolam
Moderate sedation
Dental procedural sedation
Pediatric dentistry
Additional relevant MeSH terms:
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Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents