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CompletedNCT03388957Updated Mar 24, 2021

Oral Propranolol for Reducing Pediatric Dental Patients Anxiety

An interventional study of Propranolol and Midazolam in Extrusion of Tooth, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 10 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Extrusion of Tooth
03

Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Propranolol

    Patients in this group will be given Propranolol 0.5 mg/Kg orally.

    Drug: Propranolol

  • Experimental
    Midazolam

    Patients in this group will be given Midazolam 0.5 mg/Kg orally.

    Drug: Midazolam

  • 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 · Drug: Midazolam

Interventions

  • DrugPropranolol

    This drug will be given before the extraction procedure

  • DrugMidazolam

    This drug will be given before the extraction procedure

05

What researchers measure

Primary outcomes

  1. Change in Anxiety-1 levels

    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)

    Time frame: (1) five minutes before medication, (2) 30 minutes post-extraction

  2. Change in Anxiety-2 levels

    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)

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

  3. Change in heart rate

    using Finger Pulse Oximeter

    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

Secondary outcomes

  1. Change in Behavior

    using Observational Frankl Scale "Frankl Scale": 1. Definitely negative. (Worse outcome) 2. Negative. 3. Positive. 4. Definitely positive. (Better outcome)

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

06

Study locations

1 site
  • Department of Peadodontics, University of Damascus Dental School
    Damascus, DM20AM18, Syrian Arab Republic
07

References and documents

Publications

  • Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212. PubMed 27354454 ↗
  • Gazal G, Fareed WM, Zafar MS, Al-Samadani KH. Pain and anxiety management for pediatric dental procedures using various combinations of sedative drugs: A review. Saudi Pharm J. 2016 Jul;24(4):379-85. doi: 10.1016/j.jsps.2014.04.004. Epub 2014 Apr 26. PubMed 27330369 ↗
  • Heaton LJ, McNeil DW, Milgrom P. Propranolol and D-cycloserine as adjunctive medications in reducing dental fear in sedation practice. SAAD Dig. 2010 Jan;26:27-35. PubMed 20151608 ↗
  • LeCompte MT, Rae L, Kahn SA. A survey of the use of propranolol in burn centers: Who, what, when, why. Burns. 2017 Feb;43(1):121-126. doi: 10.1016/j.burns.2016.07.007. Epub 2016 Aug 27. PubMed 27575676 ↗
  • Steenen SA, van Wijk AJ, van der Heijden GJ, van Westrhenen R, de Lange J, de Jongh A. Propranolol for the treatment of anxiety disorders: Systematic review and meta-analysis. J Psychopharmacol. 2016 Feb;30(2):128-39. doi: 10.1177/0269881115612236. Epub 2015 Oct 20. PubMed 26487439 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03388957
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Jan 3, 2018
Start date
Jul 30, 2018
Primary completion
Oct 1, 2019
Completion
Feb 15, 2020
Last update
Mar 24, 2021

Study contacts

Omar Abu Bakr, DDS
principal investigator · MSc student in Pedodontics, University of Damascus Dental School, Damascus, Syria
Mohamed Altinawi, DDS MSc PhD
study chair · Professor of Pedodontics, University of Damascus Dental School, Damascus, SYRIA
Youssef Latifeh, MD MSc Phd
study director · Professor and Head of the Psychiatry Department, Damascus Univesrity, Damascus, Syria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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