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OpenTrials
Completed

NCT Number: NCT05757648

Buffered Local Anesthetic

The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.

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Key information

Conditions

Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental Clinic of Rainbow Center for Women and Children, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy children or children with mild controlled systemic illness
  • Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration

Exclusion criteria

  • Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
  • Antibiotic premedication requirement
  • History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
  • Has signs of dental pain, odontogenic abscess or facial cellulitis
  • Allergy to local anesthetics or sulfites

Treatment and study plan

Non-buffered Anesthetic

Drug

non-buffered LA, 2% lidocaine with epinephrine 1:100,000

Buffered Anesthetic

Drug

A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.

Onset

Device

The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.

Primary outcomes

  1. Pain Score as Measured by the Behavior Pain Scale

    Time frame: Up to 10 minutes

    The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.

  2. Change in Heart Rate as Measured by as Measured by Medical Record

    Time frame: Baseline, Up to 10 minutes

  3. Change in Diastolic Blood Pressure as Measured by Medical Record

    Time frame: Baseline, Up to 10 minutes

  4. Change in Systolic Blood Pressure as Measured by Medical Record

    Time frame: Baseline, Up to 10 minutes

  5. Change in CO2 Level as Measured by Medical Record

    Time frame: Baseline, Up to 10 minutes

  6. Change in Oxygen Saturation Level as Measured by Medical Record

    Time frame: Baseline, Up to 10 minutes

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Jul 17, 2024

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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