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NCT04061265 Clinical Trial

Articaine Efficacy and Safety for Children Below Age of 4-years

Pain Clinical Trial

Official title:
Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04061265
Other study ID # 245
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 25, 2019
Est. completion date January 15, 2020

Study information
Verified date February 2020
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Recruitment information / eligibility
Status Completed
Enrollment 184
Est. completion date January 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group 37 Months to 47 Months
Eligibility Inclusion Criteria:

- Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria:

- The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml
Local anesthetic agent
• lidocaine hydrochloride 2% and epinephrine 1:100000
Local anesthetic agent

Locations
Country Name City State
Egypt Ngwa Khattab Minya Minia

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain assessment FLACC scale During the procedures
Primary Behavior Frankl behaviour scale before and after the procedures
Secondary postoperative complications Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM) 24 hours after the procedures
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