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OpenTrials
Completed

NCT Number: NCT03388957

Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

Evaluating anxiety, heart rate and behavior during dental extractions after oral dose of either Propranolol, Midazolam or a combination of both in uncooperative pediatric patients.

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Key information

Conditions

Extrusion of Tooth

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Peadodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

Use of 0.5 mg/kg of Propranolol or a combination of Propranolol and Midazolam for the first time to manage uncooperative pediatric dental patients anxiety, comparing with Midazolam by evaluating anxiety, heart rate and behavior during administration of local anesthesia and extraction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • High to extreme fear of tooth or molar anesthesia and removal (Frankl: Definitely negative).
  • Scoring more than 19 points on MCDAS(f).
  • Healthy pediatric patients (ASA I) aging 8-10 years.
  • Indication for primary tooth or molar extraction.
  • Fasting if indicated (severe gag reflex).
  • Airway assessment (Mallampati and tonsillar hypertrophy).

Exclusion criteria

  • Asthma or any other obstructive pulmonary disease.
  • Cardiac failure.
  • Cardiac arrhythmia.
  • Renal failure.
  • Diabetes.
  • Current use of another ß-adrenoreceptor antagonist.
  • Current use of anxiolytic or antidepressant medication.
  • Currently in psychotherapy for dental anxiety.
  • Systolic blood pressure <100 mmHg.
  • Diastolic blood pressure <60 mmHg.
  • Active Upper respiratory infection.

Treatment and study plan

Propranolol

Drug

This drug will be given before the extraction procedure

midazolam

Drug

This drug will be given before the extraction procedure

Primary outcomes

  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):

    • Relaxed/Not worried. (Better outcome)
    • Very slightly worried.
    • Fairly worried.
    • Worried a lot.
    • 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)
    • Uneasy.
    • Tense.
    • Reluctant.
    • Interference.
    • Out of contact. (Worse outcome)

  3. Change in heart 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

Secondary outcomes

  1. Change in Behavior

    Time frame: (1) 45 minutes after medication, while applying local anesthesia, (2) after 10 minutes of applying the anesthesia and during tooth extraction

    using Observational Frankl Scale "Frankl Scale":

    • Definitely negative. (Worse outcome)
    • Negative.
    • Positive.
    • Definitely positive. (Better outcome)

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluating of Oral Propranolol Effect on Managing Anxiety of Dental Extractions in Children: A Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 3, 2018
Registry last updated
Mar 24, 2021

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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