Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment

Pain Management Clinical Trial

Official title:

Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176446
• Other study ID #: 64773417.3.0000.5689
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2020
• Source: Universidade Estadual de Ponta Grossa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. The objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. Will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological and behavioral criteria. For the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong Baker Faces. The results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 1, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla.

Exclusion Criteria:

• The person responsible does not authorize the participation of the child as a research volunteer.

• Be using pain modulating drugs.

• Be using anxiety modulating drugs.

• Patients with a history of hypersensitivity to local anesthetics.

• Patients with a history of systemic diseases.

Related Conditions & MeSH terms

• Local Anesthesia
• Pain Management
• Pediatric Dentistry

Intervention

Device:
• Local anesthesia with traditional technique
Puncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min
• Local anesthesia with computerized technique
Puncture with short needle in the region of the apical third of the tooth to be anesthetized according to the recommendations of the manufacturer Injection of local anesthetic with computerized anesthesia equipment, with speed 0.5 ml / min
• Local anesthesia with DentalVibe technique
Use of DentalVibe in the apical region of the tooth to be anesthetized according to the manufacturer's guidelines Puncture with short needle enters the tips of the DentalVibe Injection of local anesthetic with traditional carpule, with speed 1 ml / min

Drug:
• Topic anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
• Local anesthetic
2% lidocaine with epinephrine 1: 100000 1.8 mL

Locations

Country	Name	City	State
Brazil	Ponta Grossa State University	Ponta Grossa	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Ponta Grossa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-perception of pain	The pain will be analyzed by the Wong Baker Faces scales	Immediately after anesthesia
Primary	Pain Behavior	The pain will be analyzed by the FLACC	During the anesthetic procedure
Primary	Self-perception of pain	The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain	Immediately after anesthesia
Secondary	SCARED Questionnaire	Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire	Before anesthesia
Secondary	Corah Questionnaire	Children will be evaluated for the dentistry anxiety prior to any anesthesia	Before anethesia
Secondary	VPT modified	Children will be evaluated for the anxiety after to any anesthesia	Before anethesia and immediately after anesthesia
Secondary	Blood pressure	The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure	Immediately before anesthesia, during anesthesia
Secondary	Respiratory rate	The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate	Immediately before anesthesia, during anesthesia
Secondary	Heart rate	The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate	Immediately before anesthesia, during anesthesia
Secondary	Oxygen saturation	The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation	Immediately before anesthesia, during anesthesia
Secondary	Salivary cortisol	The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol	Immediately before anesthesia, during anesthesia