NCT02591797

Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children

Effectiveness of Hand/Eyes/Mouth Behavior Management Technique in Anxiety, Pain and Behavior Levels During an Inferior Alveolar and Lingual Nerve Block Procedure in Preschool Children: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Cardenal Herrera University · Academic / Other
• Sex: All
• Age: 36 Months – 71 Months
• Healthy volunteers: Not accepted

Summary

This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.

Detailed description

Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)"Hands/Eyes/mouth" and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank

Conditions

• Dental Anxiety
• Pain
• Infant Behavior
• Heart Rate and Rhythm Disorders

Interventions

Type	Name	Description
PROCEDURE	inferior alveolar and lingual nerve block procedure	The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution. The application of anesthesia shall be in accordance with the following guidelines: 1. Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). 2. Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) 3. anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). 4. Syringe: carpule syringe-conventional harpoon with suction system.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2015-10-30
• Last updated: 2017-07-19

Locations

1 site across 1 country: Spain