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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591797
• Other study ID #: AMLUCHBR
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: July 17, 2017
• Start date: October 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 71 Months

Eligibility

Inclusion Criteria:

• Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars

Exclusion Criteria:

• Preschool children with history of allergies to lidocaine (local anesthetic)

• Preschool children with systemic or neurological diseases

• Preschool children who have received local dental anesthesia before this study

• Preschool children who do not understand Spanish or Valencian language

Related Conditions & MeSH terms

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

Intervention

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: Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain). Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain) anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain). Syringe: carpule syringe-conventional harpoon with suction system.

Locations

Country	Name	City	State
Spain	Facultad de Odontología. Universidad Cardenal Herrera CEU	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preschool children´s behavior-Frank behavioral rating Scale	It will be evaluated children´s behavior (definitely negative, negative,definitely positive, positive)during the local anethesia procedure	baseline and during the local anesthesia procedure (2 minutes)
Other	Heart rates		baseline and during the local anesthesia procedure (2 minutes)
Primary	Preschool children´s anxiety levels-Facial Image Scale (FIS)	The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy-FIS)	Baseline
Secondary	Preschool children´s pain levels-Wong Baker Faces Pain Scale	The children will be asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine)	At the end of local anesthesia procedure (2 minutes)