Clinical trial NCT03176446: Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
Official title: Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Dentistry
Local Anesthesia
Pain Management
Lead sponsor: Universidade Estadual de Ponta Grossa
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 210
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The total sample is divided into two subgroups, with 105 children aged 5 to 8 years and 105 children aged 9 to 12 years. The analysis is more sensitive and specific to each subgroup. The results of each subgroup will be analyzed in isolation and give rise to two different papers.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Self-perception of pain
timeFrame: Immediately after anesthesia
measure: Pain Behavior
timeFrame: During the anesthetic procedure
measure: Self-perception of pain
timeFrame: Immediately after anesthesia
Secondary outcomes:
measure: SCARED Questionnaire
timeFrame: Before anesthesia
measure: Corah Questionnaire
timeFrame: Before anethesia
measure: VPT modified
timeFrame: Before anethesia and immediately after anesthesia
measure: Blood pressure
timeFrame: Immediately before anesthesia, during anesthesia
measure: Respiratory rate
timeFrame: Immediately before anesthesia, during anesthesia
measure: Heart rate
timeFrame: Immediately before anesthesia, during anesthesia
measure: Oxygen saturation
timeFrame: Immediately before anesthesia, during anesthesia
measure: Salivary cortisol
timeFrame: Immediately before anesthesia, during anesthesia
Other outcomes:
Locations:
city: Ponta Grossa
country: Brazil
facility: Ponta Grossa State University
state: Paraná
Study officials:
References: