Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children

NCT04477317 | Completed Phase 3

• 1 other identifier: local anesthesia in chilldren
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.

Conditions

Local Anesthesia

Outcome Measures

Primary Outcomes (1)

• Intra-operative pain during extraction

  measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale

  through study completion, an average of 1 year

Secondary Outcomes (2)

• onset of anesthesia

  through study completion, an average of 1 year

• duration of anesthesia

  through study completion, an average of 1 year

Study Arms (2)

Experimental

EXPERIMENTAL

4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt).

Drug: 4% Articaine Hydrochloride with 1:100,000 Adrenaline

Control

ACTIVE COMPARATOR

2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt)

Drug: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin

Interventions

4% Articaine Hydrochloride with 1:100,000 Adrenaline DRUG

new Egyptian articane anesthetic solution.

Also known as: %4 Alexadricaine

Experimental

2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin DRUG

Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.

Also known as: 2% Mepicaine-L

Control

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medically fit (ASA I, II).
• Mentally capable of communication.
• Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
• First maxillary primary molar needs extraction due to root caries "beyond possible repair".
• First dental visit.
• Child must give assent prior to participation, as well as approved parental informed written consent.

You may not qualify if:

• Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
• Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Carticaine; Epinephrine; Mepivacaine; Nordefrin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Norepinephrine

Study Officials

• Sara A mahmoud, Assoc. Prof.

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: August 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

EG (1)