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Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

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ClinicalTrials.gov Identifier: NCT03388957
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:
Evaluating anxiety, behavior, sedation and vital signs during dental extraction after orally taking either propranolol, midazolam, a combination of both or placebo in 6-9 years old uncooperative patients.

Condition or disease Intervention/treatment
Extrusion of Tooth Drug: Propranolol Drug: Midazolam

Detailed Description:
Use of 0.5 mg/kg propranolol and a combination of propranolol and midazolam for the first time to manage 6-9 years old uncooperative pediatric dental patients anxiety, comparing with midazolam and placebo by evaluating anxiety, behavior, sedation and vital signs before, during and after treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Four groups, with 20 children in each group
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial
Actual Study Start Date : September 30, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Propranolol
Patients in this group will be given Propranolol 0.5 mg/Kg orally.
Drug: Propranolol
This drug will be given before the extraction procedure
Experimental: Midazolam
Patients in this group will be given Midazolam 0.5 mg/Kg orally.
Drug: Midazolam
This drug will be given before the extraction procedure
Experimental: Propranolol and Midazolam
Patients in this group will be given Propranolol and Midazolam with a dose of 0.5 mg/Kg orally for each drug.
Drug: Propranolol
This drug will be given before the extraction procedure
Drug: Midazolam
This drug will be given before the extraction procedure
No Intervention: Placebo
A placebo drug will be given in this group.



Primary Outcome Measures :
  1. Change in Anxiety-1 levels [ Time Frame: (1) five minutes before medication, (2) 30 minutes post-extraction ]

    Anxiety-1 levels will be evaluated using self-reported faces anxiety scale (also called 'modified child dental anxiety scale). Scale name: Modified Child Dental Anxiety Scale (MCDAS):

    1. Relaxed/Not worried. (Better outcome)
    2. Very slightly worried.
    3. Fairly worried.
    4. Worried a lot.
    5. Very worried. (Worse outcome)

  2. Change in Anxiety-2 levels [ Time Frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction. ]

    Anxiety-2 levels will be measured using Observational Venham Anxiety Scale

    Major Issues: 1) Will be measured in 2 phases:

    • 45 minutes after medication, while applying local anesthesia.
    • While extracting the tooth. "Venham Anxiety Scale": 0. Relaxed. (Better outcome)

      1. Uneasy.
      2. Tense.
      3. Reluctant.
      4. Interference.
      5. Out of contact. (Worse outcome)


Secondary Outcome Measures :
  1. Change in Behavior [ Time Frame: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction ]

    using Observational Frankl Scale "Frankl Scale":

    1. Definitely negative. (Worse outcome)
    2. Negative.
    3. Positive.
    4. Definitely positive. (Better outcome)

  2. Change in Sedation status [ Time Frame: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction ]

    using "University of Michigan Sedation Scale (UMSS)": 0. Awake and alert.

    1. Minimally sedated.
    2. Moderately sedated.
    3. Deeply sedated.
    4. Unarousable. (Increasing score with high sedation level)

  3. Change in pulse rate [ Time Frame: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction ]
    using Finger Pulse Oximeter

  4. Change in Oxygen Saturation [ Time Frame: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction ]
    using Finger Pulse Oximeter

  5. Change in Blood Pressure [ Time Frame: (1) 5 minutes before medication, (2) 45 minutes after medication, while applying local anesthesia, (3) after 10 minutes of applying the anesthesia and during tooth extraction, (4) 30 minutes following extraction ]
    using Wrist Automatic Digital Blood Pressure Monitor



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High to extreme fear of tooth or molar anesthesia and removal (Frankl: Negative).
  • Scoring more than 19 points on MCDAS(f).
  • 6-9 years old healthy pediatric patients (ASA I).
  • Indication for primary tooth or molar extraction.
  • Fasting if indicated (severe gag reflex).
  • Airway assessment (Mallampati and tonsillar hypertrophy).

Exclusion Criteria:

  • Asthma or other obstructive pulmonary disease.
  • Cardiac failure.
  • Cardiac arrhythmia.
  • Renal failure.
  • Insulin-dependent diabetes mellitus.
  • Current use of another ß-adrenoreceptor antagonist.
  • Current use of anxiolytic or antidepressant medication.
  • Currently in psychotherapy for dental anxiety.
  • Systolic blood pressure <10 mmHg.
  • Diastolic blood pressure <6 mmHg.
  • Extreme obesity (BMI).
  • Active Upper respiratory infection.

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): NCT03388957


Contacts
Contact: Omar Abu Bakr, DDS 00963933050639 omarabubakr2009@gmail.com
Contact: Mohamed Altinawi, DDS MSc PhD 00963955358197 mohamedaltinawi@gmail.com

Locations
Syrian Arab Republic
Department of Peadodontics, University of Damascus Dental School Recruiting
Damascus, Syrian Arab Republic, DM20AM18
Contact: Mohamed Altinawi, DDS MSc PhD    00963955358197    mohamedaltinawi@gmail.com   
Principal Investigator: Omar Abu Bakr, DDS         
Sponsors and Collaborators
Damascus University
Investigators
Principal Investigator: Omar Abu Bakr, DDS MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
Study Chair: Mohamed Altinawi, DDS MSc PhD Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA
Study Director: Youssef Latifeh, MD MSc Phd Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria

Publications:
Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03388957     History of Changes
Other Study ID Numbers: UDDS-Pedo-02-2017
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Midazolam
Propranolol
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents