Compare the Efficacy of Various Pain Alleviating Methods in Reducing Pain in Children During Intraoral Local Anaesthetic Injections

NCT05564442 | Unknown DMC

• 1 other identifier: 581/2022
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites compared with 20% benzocaine gel in reducing pain in children requiring anesthesia during routine dental procedures.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (6)

• Baseline Heart Rate ( beats/min )

  Heart Rate will be measured by using digital manometerReading will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

  mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]

• Heart Rate Measurement after Local Anaesthetic Administration( beats/min )

  Heart Rate will be measured by using digital manometer .Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

  After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4

• Baseline blood pressure systolic and diastolic ( mm Hg)

  The blood pressure is most often measured in the arm when the patient is seated. Blood pressure readings taken in supine position tend to be lower than those taken in sitting position. Standards for blood pressure readings are based upon the seated position using the right arm.

  mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2 ]

• Blood pressure measurment (systolic and diastolic)after local anesthetic administration ( mm Hg )

  The blood pressure is most often measured in the arm when the patient is seated. Blood pressure readings taken in supine position tend to be lower than those taken in sitting position. Standards for blood pressure readings are based upon the seated position using the right arm.

  After local anaesthetic solution delivery. Time frame is approximately minute 2 - 4

• The FLACC scale or Face, Legs, Activity, Cry, Consolability scale

  The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

  Approximately 2-4 minute after injection.

• Wong-Baker Faces Pain Rating Scale

  The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".

  Approximately 2-4 minute after injection.

Study Arms (4)

Group I: Children received 20% benzocaine gel

ACTIVE COMPARATOR

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Drug: 20% benzocaine gel

Group II: Children received TENS stimuli

ACTIVE COMPARATOR

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Device: Transcutaneous electric nerve stimuli

Group III: Children received EMLA gel.

ACTIVE COMPARATOR

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Drug: Emla gel

Group IV: Children received ice application at injection site

ACTIVE COMPARATOR

Comparative Evaluation of Different Pain Alleviating Methods During Intra-oral Local Anesthetic Injections

Other: Ice application

Interventions

20% benzocaine gel DRUG

compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.

Group I: Children received 20% benzocaine gel

Transcutaneous electric nerve stimuli DEVICE

compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.

Group II: Children received TENS stimuli

Emla gel DRUG

compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.

Group III: Children received EMLA gel.

Ice application OTHER

compare the efficacy of various pain alleviating methods by application of Emla gel, TENS, and topical cooling of injection sites with 20% benzocaine gel in children 6-10 years requiring anesthesia during routine dental procedures.

Group IV: Children received ice application at injection site

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Class I and Class II relaying on ASA classification
• Children of the age-group 6-10 years were included in this study.
• Children who are never exposed to TENS, EMLA jelly,
• Children who require LA injections and in whom parental consent was obtained.
• Patients requiring LA for dental procedures such as pulpotomy, or extraction procedure.
• Definitely positive on frankel scale.

You may not qualify if:

• Children with epileptic disorder.
• Children with a history of cardiac and bleeding disorder.
• Immature children who cannot understand the concept of pain.
• Physically and mentally challenged children.
• Subjects allergic to LA drugs or cartridge components
• Patients having behavioral management problems.
• Patients having previous negative dental experience.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

El Minia university

Minya, Egypt

RECRUITING

Study Officials

• Bahy Ibarhim Abdelfatah

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahy Ibrahim Abdelfatah

CONTACT

01021941938; Bahyelmelegy63@gmail.com

Mina Kamal Yassa, Phd

CONTACT

0 111 5332387

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: October 3, 2022
• Study Start: June 5, 2022
• Primary Completion: December 10, 2022
• Study Completion: February 1, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

EG (1)