Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

Damascus University

Status: Completed

Conditions: Extrusion of Tooth

Treatments: Drug: Micro-needle patches dissolved with EMLA Cream; Other: Conventional local palatine injection; Drug: Oral patches with EMLA Cream; Drug: EMLA cream only; Drug: chemical permeability enhancer DMSO with EMLA cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05187494

UDDS-Pedo-05-2021

Details and patient eligibility

About

The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection.

Group 1: Conventional local palatine injection (control group). Group 2: EMLA cream only. Group 3 :chemical permeability enhancer DMSO with EMLA cream. Group 4: Oral patches with EMLA Cream. Group 5: Micro-needle patches dissolved with EMLA Cream.

Full description

The insertion of the needle and the infusion of the anesthetic solution into the palate often uncomfortable for the children and their acceptance of dental treatment. Therefore, there is a need for studies to find ways to replace the palatine injection in the modern dentistry.

Effectiveness of Compound surfactant drugs (EMLA) have strong activity on the palatine tissues. Therefore, it will be chosen as an alternative to the traditional ones and will be enhanced by one of the drug delivery systems (physical/chemical).

Decreased permeability of the palatine mucosa is a major reason behind using drug delivery systems to reach an effective therapeutic level.

To our knowledge, this research will be the first which will be used a method of drug delivery systems to replace traditional palatal needle.

Enrollment: 75 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• no previous dental experience.
• Healthy children.
• Definitely positive or positive ratings of Frank scale
• Child did not receive any sedative or pain drugs during the last three.
• Presence of upper primary teeth, an indication for extraction

Exclusion criteria

• Presence of general diseases or health problems.
• Uncooperative children
• Children with congenital or idiopathic Methemoglobin
• Teeth with severe abscesses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 5 patient groups

Conventional local palatine injection

Other group

Description:

Conventional palatal injection with anesthetic (lidocaine 2% with Epinephrine 1:80000, Korea) will be performed and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.

Treatment:

Other: Conventional local palatine injection

EMLA cream only

Experimental group

Description:

The palatine mucosa will be dried with a cotton ball 2\*2 and then 0,2 g of Emla cream will be applied for 3 minutes . During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.

Treatment:

Drug: EMLA cream only

chemical permeability enhancer DMSO with EMLA cream

Experimental group

Description:

The palatine mucosa will be dried with a cotton ball and then EMLA cream will be mixed with a permeability enhancer in the laboratory of pharmaceutical industries at the Faculty of Pharmacy at Damascus University according to the following: Adding 10 g of EMLA cream 5%, 1,026 g of DMSO 100% and it will be applied with cotton bud for a period of 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.

Treatment:

Drug: chemical permeability enhancer DMSO with EMLA cream

Oral patches with EMLA Cream

Experimental group

Description:

The palatine mucosa will be dried with a cotton ball and then 0.2 g of EMLA cream 5% will be applied by using an oral patch 14\*14 mm for 3 minutes. During this period and the following measures (face expressions ( Wong-Baker Faces) heart rate and oxygen rate and FLACC pain scale) will be recorded to determine the reaction of the child.

Treatment:

Drug: Oral patches with EMLA Cream

Micro-needle patches dissolved with EMLA Cream

Experimental group

Description:

The palatine mucosa will be dried with a cotton ball 2\*2 and then 0.2 g of EMLA cream 5% will be applied by using an micro-needle patch 14\*14 mm, 0,25 micron for 3 minutes.

Treatment:

Drug: Micro-needle patches dissolved with EMLA Cream