Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

Not Applicable

Completed

• Conditions: Extrusion of Tooth
• Interventions: Drug: Oral patches with EMLA Cream; Drug: Micro-needle patches dissolved with EMLA Cream; Other: Conventional local palatine injection; Drug: chemical permeability enhancer DMSO with EMLA cream; Drug: EMLA cream only

• Registration Number: NCT05187494
• Lead Sponsor: Damascus University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-20
• Primary Completion: 2021-08-23
• Study Completion: 2021-09-27
• Status Verified: 2021-12
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral patches with EMLA Cream	Oral patches with EMLA Cream	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.
Micro-needle patches dissolved with EMLA Cream	Micro-needle patches dissolved with EMLA Cream	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.
Conventional local palatine injection	Conventional local palatine injection	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.
chemical permeability enhancer DMSO with EMLA cream	chemical permeability enhancer DMSO with EMLA cream	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.
EMLA cream only	EMLA cream only	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.

Primary Outcome Measures

Name	Time	Method
Changes in the values of each of the heart rate and oxygen rate	On application of the substance	The heart and oxygen rate will be recorded by pulse oximeter
Evaluation conventional local palatine injection	On extraction	The heart and oxygen rate will be recorded by pulse oximeter
Pain levels using self-reported Wong-Baker faces pain scale	On extraction	0= "no hurt", 2= "hurts a little bit", 4="hurts a little more", 6= "hurts even more", 8= "hurts a whole lot", 10= "hurts worst"
Pain levels using FLACC scale	On extraction	0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic