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Completed

NCT Number: NCT04317508

Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.

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Key information

Conditions

Anesthesia, Dental Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.

A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children ranging in age from 6 to 8 years.
  • Healthy children with no contraindications of use of local anesthetics.
  • Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I)
  • Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.

Exclusion criteria

  • Uncooperative children or with intellectual or physical disabilities or medical conditions.
  • Children with acute pain or emergency visits.
  • Children with previous negative dental experience.
  • Children receiving premedications or analgesics 48 hours before testing.
  • children/parents not willing to participate.

Treatment and study plan

Topicale GelPatch (Benzocaine 18%)

Drug

Intervention group

Benzocaine oral gel 20%

Drug

control group

Primary outcomes

  1. Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection

    Time frame: 4 months

    The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale

    Sound, Eye, Motor scale:

    Grade 1: Comfort

    • Sound: No sound
    • Eye: No signs
    • Motor: Relaxed body and hand

    Grade 2: Mild discomfort

    • Sound: Non specific sound
    • Eye: Dilated without tears
    • Motor: Muscular contractions of hand

    Grade 3: Moderate discomfort

    • Sound: Verbal compliant, louder sound
    • Eye: Tears, sudden eye movement
    • Motor: Sudden body and hand movements

    Grade 4: Severe discomfort

    • Sound: Verbal compliant shouting, crying
    • Eye: Crying, tears all over face
    • Motor: Hand movement for defense, Turning the head to opposite side

  2. Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection

    Time frame: 4 months

    Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R).

    2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" = "no pain" and "10" = "very much pain".

Sponsors and collaborators

Lead sponsor

Dina Youssef Attia

Other

Registry information

Official study title

Effectiveness of Benzocaine Gelpatch in Reducing Injection Pain in Pediatric Dental Patients:A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2020
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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