Pain Clinical Trial
Official title:
Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children. A Double Blinded Randomized Controlled Clinical Trial.
The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm[37°C] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | June 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: 1. Children requiring maxillary infiltration LA for dental treatment. 2. Cooperative children (positive or definitely positive on Frankel's scale). 3. Children are in apparently good health and not taking any medications that will alter their pain perception. 4. Children have no history of allergy to Mepivacaine Exclusion Criteria: 1. The person responsible does not authorize the participation of the child as a research volunteer. 2. Be using pain modulating drugs. 3. Patients with a history of hypersensitivity to local anesthetics. 4. Patients with a history of systemic diseases. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Aravena PC, Barrientos C, Troncoso C, Coronado C, Sotelo-Hitschfeld P. Effect of warming anesthetic on pain perception during dental injection: a split-mouth randomized clinical trial. Local Reg Anesth. 2018 Feb 22;11:9-13. doi: 10.2147/LRA.S147288. eCollection 2018. — View Citation
Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. — View Citation
Ram D, Hermida LB, Peretz B. A comparison of warmed and room-temperature anesthetic for local anesthesia in children. Pediatr Dent. 2002 Jul-Aug;24(4):333-6. — View Citation
Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Behavoir | The pain will be analyzed by sound ,eye motor scale An assistant will be trained to measure and calibrate the SEM scale. The assistant will be blinded to the study group to avoid bias. | During the anesthetic procedure | |
Primary | Self-perception of pain | The pain will be analyzed by the Wong Baker Faces scales
. A set of six cartoon faces will be shown to the child with varying facial expressions ranging from a very smiling face to a very sad face. A brief explanation will be given to the child about each face after which the child will be instructed to choose the face that will describe his/ her feelings while receiving local anesthesia |
Immediately after anesthesia |
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