Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

NCT05187494 | Completed

• 1 other identifier: UDDS-Pedo-05-2021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Extrusion of Tooth

Keywords

EMLA; Micro-needle patches; Permeability enhancer; Oral patches

Outcome Measures

Primary Outcomes (9)

• Changes in the values of each of the heart rate and oxygen rate

  The heart and oxygen rate will be recorded by pulse oximeter

  On application of the substance

• Evaluation conventional local palatine injection

  The heart and oxygen rate will be recorded by pulse oximeter

  On palatal probing

• Evaluation conventional local palatine injection

  The heart and oxygen rate will be recorded by pulse oximeter

  On extraction

• Pain levels using self-reported Wong-Baker faces pain scale

  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"

  On application of the substance

• Pain levels using self-reported Wong-Baker faces pain scale

  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"

  On palatal probing

• Pain levels using self-reported Wong-Baker faces pain scale

  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"

  On extraction

• Pain levels using FLACC scale

  0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain

  On application of the substance

• Pain levels using FLACC scale

  0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain

  On palatal probing

• Pain levels using FLACC scale

  0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 =Moderate pain, 7-10 = Severe discomfort/pain

  On extraction

Study Arms (5)

Conventional local palatine injection

OTHER

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.

Other: Conventional local palatine injection

EMLA cream only

EXPERIMENTAL

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.

Drug: EMLA cream only

chemical permeability enhancer DMSO with EMLA cream

EXPERIMENTAL

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.

Drug: chemical permeability enhancer DMSO with EMLA cream

Oral patches with EMLA Cream

EXPERIMENTAL

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.

Drug: Oral patches with EMLA Cream

Micro-needle patches dissolved with EMLA Cream

EXPERIMENTAL

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.

Drug: Micro-needle patches dissolved with EMLA Cream

Interventions

Conventional local palatine injection OTHER

Conventional palatal injection with anesthetic (lidocaine HCL2% with Epinephrine 1:80000, Korea) Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness

Conventional local palatine injection

EMLA cream only DRUG

Emla cream will be applied at a distance of 1 mm from the palatine gingival edge by cotton buds for 3 minutes within the application area 14\*14 mm and the mouth will be open throughout the procedure and the saliva will be controlled by a saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.

EMLA cream only

chemical permeability enhancer DMSO with EMLA cream DRUG

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 while the child is opening his mouth and the saliva is controlled by saliva absorbent. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.

chemical permeability enhancer DMSO with EMLA cream

Oral patches with EMLA Cream DRUG

EMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an oral patch 14\*14 mm for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness

Oral patches with EMLA Cream

Micro-needle patches dissolved with EMLA Cream DRUG

EMLA cream 5% will be applied at a distance of 1 mm from the palatal gingival edge using an micro-needle patch 14\*14 mm, 0,25 micron for 3 minutes and the Mouth will be closed throughout the procedure. Then the palatal probe will be performed with a dental probe in contact with the bone to estimate anesthetic effectiveness.

Micro-needle patches dissolved with EMLA Cream

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (5)

• Munshi AK, Hegde AM, Latha R. Use of EMLA: is it an injection free alternative? J Clin Pediatr Dent. 2001 Spring;25(3):215-9. doi: 10.17796/jcpd.25.3.hn62713500418728.

  PMID: 12049081 BACKGROUND

• Davidovich E, Wated A, Shapira J, Ram D. The influence of location of local anesthesia and complexity/duration of restorative treatment on children's behavior during dental treatment. Pediatr Dent. 2013 Jul-Aug;35(4):333-6.

  PMID: 23930632 BACKGROUND

• Barcohana N, Duperon DF, Yashar M. The relationship of application time to EMLA efficacy. J Dent Child (Chic). 2003 Jan-Apr;70(1):51-4.

  PMID: 12762609 BACKGROUND

• Franz-Montan M, Ribeiro LNM, Volpato MC, Cereda CMS, Groppo FC, Tofoli GR, de Araujo DR, Santi P, Padula C, de Paula E. Recent advances and perspectives in topical oral anesthesia. Expert Opin Drug Deliv. 2017 May;14(5):673-684. doi: 10.1080/17425247.2016.1227784. Epub 2016 Sep 1.

  PMID: 27554455 BACKGROUND

• Shaikh R, Raj Singh TR, Garland MJ, Woolfson AD, Donnelly RF. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci. 2011 Jan;3(1):89-100. doi: 10.4103/0975-7406.76478.

  PMID: 21430958 BACKGROUND

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination; Transdermal Patch

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Equipment and Supplies

Study Officials

• Farah M Babakurd, DDS

  MSc student in Pedodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Shadi K Azzawi, Phd

  Professor of Pedodontics, Department of Pedodontics, University of Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 11, 2022
• Study Start: May 20, 2021
• Primary Completion: August 23, 2021
• Study Completion: September 27, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)