Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

Evaluation of Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction: Randomized Controlled Clinical Trial

The aim of this study is to analyze the effectiveness of articaine in controlling self-reported pain compared with conventional lidocaine anesthesia in children requiring extraction of deciduous maxillary molars. Only one extraction will be performed on each child. At least two consultations will be necessary to carry out the present controlled, randomized, and blinded study. All participants will be treated by the same dentist. Self-reported pain will be assessed using the Visual Analogue Scale.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Dental Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: Articaine

Detailed Description

In the present study, self-reported pain during extraction of a maxillary primary molar with one buccal infiltration anesthesia with articaine will be compared with the conventional technique (buccal infiltration and palatal supplementation) with lidocaine. The study design will be a blind, controlled, randomized, non-inferiority clinical trial with two parallel groups. The anesthetic will be administered according to the weight of the child, using a table with the amount of anesthetic per weight group and the maximum recommended dose as reference. The hypothesis is that articaine, due to its anesthetic properties, is able to anesthetize as well as lidocaine with only one oral infiltration, without the need for additional anesthesia, which may guarantee better participant comfort, less dental anxiety, and less chair time. The use of the Visual Analogue Scale is important to assess the pain perceived by the children and to ensure the reliability of the responses. Participant comfort will be evaluated at each stage of the proposed treatment, and withdrawal from participation will be guaranteed at any time.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Danielle Rigo, MSc.; Phone Number: +5548998299559; Email: dani-riggo@hotmail.com

Study Locations

• Brazil
  • Florianópolis, Brazil
    • Recruiting
    • Centro de Especialidades Odontológicas (CEO)
    • Contact: Marynes Reibnitz, M.Sc
    • Principal Investigator: Danielle Rigo
    • Sub-Investigator: Aurélio Rocha
    • Sub-Investigator: Pablo Santos
    • Sub-Investigator: Barbara Moccelini
  • Palhoça, Brazil
    • Recruiting
    • Centro de Especialidades Odontológicas (CEO)
    • Principal Investigator: Danielle Rigo
    • Sub-Investigator: Aurélio Rocha
    • Sub-Investigator: Pablo Santos
    • Sub-Investigator: Barbara Moccelini
    • Contact: Suelen Pagliari
  • Santa Catarina, Brazil
    • Recruiting
    • Universidade Federal de Santa Catarina - USFC
    • Principal Investigator: Danielle Rigo
    • Sub-Investigator: Aurélio Rocha
    • Sub-Investigator: Pablo Santos
    • Sub-Investigator: Barbara Moccelini
    • Contact: Cardoso Mariane, PhD
  • São José, Brazil
    • Recruiting
    • Centro de Especialidades Odontológicas (CEO)
    • Principal Investigator: Danielle Rigo
    • Sub-Investigator: Aurélio Rocha
    • Sub-Investigator: Pablo Santos
    • Sub-Investigator: Barbara Moccelini
    • Contact: Jaíne da Luz, M.Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical criteria: the presence of coronary destruction precluding restoration or adequate use of absolute isolation for endodontic and restorative procedures; perforation of the pulp chamber floor.
• Radiographic criteria: deciduous molars with at least one non-resorbed half-length root presenting carious lesions or defective restorations associated with signs or symptoms suggestive of pulp necrosis with endodontic contraindication (periapical or interradicular lesion extending over more than half of the roots or involving the crypt of the permanent successor tooth; the presence of pathologic resorption of more than 1/3 of one or more roots; failure of endodontic treatment with the persistence of periapical or inter-radicular lesion with or without clinical signs and symptoms; internal resorption).

Exclusion Criteria:

• Participants with acute pain or presence of odontogenic infection associated with systemic signs and symptoms and in cases of urgency;
• History of bleeding or blood clotting problems or taking medications that alter blood clotting prior to the procedure;
• Hypersensitivity or history of allergy to the drugs used in the research;
• Asthma;
• History of liver disease;
• History of sulfite allergy;
• Report of post-traumatic stress disorders or recurrent hospitalizations, personality or anxiety disorders, diagnosis of phobias or definite uncooperative behavior;
• Neurological disorders or communication difficulties;
• Use of analgesic or anti-inflammatory medications up to 5 hours before the procedure;
• Parents or guardians unable to be available for follow-up and/or respond to information necessary for the survey within 24 hours of the procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine; Forty-eight (48) children will receive conventional infiltration anesthesia (buccal infiltration injection followed by complementary injections on the palatal region) with 2% lidocaine and 1:100,000 epinephrine at a dose previously calculated by weight. Two-thirds of the anesthetic will be injected into the buccal area and 1/3 into the palatal area. Other Names: Control Group	Drug: Lidocaine; A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.; Other Names: Control Grup
Experimental: Articaine; Forty-eight (48) children will receive a single buccal infiltration injection with 4% articaine and 1:100,000 epinephrine at a dose previously calculated by weight. Other Names: Test Group	Drug: Articaine; A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.; Other Names: Test Grup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Pain	Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)	Immediately after the maxillary primary molar extraction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Pain	Pain is evaluated by the outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (FLACC 0-10 score, higher values represent a worse outcome) and the Faces Pain Scale - Revised (FBRS 0-10 score, higher values represent a worse outcome)	During the injection of local anesthesia and the surgical procedure
Dental Pain	Self-assessment of pain using the Wong-Baker FACES Pain Rating Scale (FACES 0-10 score, higher values represent a worse outcome)	Immediately after the injection of local anesthesia and the maxillary primary molar extraction
Dental Pain	Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)	Immediately after the injection of local anesthesia
Heart rate variability	Heart rate variability to be verified and recorded with the heart rate sensor (Polar H-10)	Immediately before, durin, and immediately after the surgical procedure
Heart rate	Heart rate to be verified and recorded at moments described above carried out with the heart rate sensor (Polar H-10) and pulse oximeter	Immediately before, durin, and immediately after the surgical procedure
Evaluation of Post-surgical Pain	Self-assessment of pain using a Visual Analogue Scale (VAS 0-100 mm, higher values represent a worse outcome) and the Faces Pain Scale - Revised (FBRS 0-10 score, higher values represent a worse outcome) in the postoperative period. It will be applied through teleconsultation	24 hours after the surgical procedure

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Investigators: Study Director: Mariane Cardoso, PhD, Universidade Federal de Santa Catarina - UFSC; Study Director: Carla Santana, PhD, Universidade Federal de Santa Catarina - UFSC

Publications and helpful links

General Publications

• Taneja S, Singh A, Jain A. Anesthetic Effectiveness of Articaine and Lidocaine in Pediatric Patients During Dental Procedures: A Systematic Review and Meta-Analysis. Pediatr Dent. 2020 Jul 15;42(4):273-281.
• Tirupathi SP, Rajasekhar S. Can single buccal infiltration with 4% articaine induce sufficient analgesia for the extraction of primary molars in children: a systematic literature review. J Dent Anesth Pain Med. 2020 Aug;20(4):179-186. doi: 10.17245/jdapm.2020.20.4.179. Epub 2020 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; lidocaine; child; articaine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Carticaine
• Other Study ID Numbers: 030422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No