Buffered Local Anesthetic

NCT05757648 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY20191693
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dental Pain

Keywords

Dental surgery; Deep sedation

Outcome Measures

Primary Outcomes (6)

• Pain Score as Measured by the Behavior Pain Scale

  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.

  Up to 10 minutes

• Change in Heart Rate as Measured by as Measured by Medical Record

  Baseline, Up to 10 minutes

• Change in Diastolic Blood Pressure as Measured by Medical Record

  Baseline, Up to 10 minutes

• Change in Systolic Blood Pressure as Measured by Medical Record

  Baseline, Up to 10 minutes

• Change in CO2 Level as Measured by Medical Record

  Baseline, Up to 10 minutes

• Change in Oxygen Saturation Level as Measured by Medical Record

  Baseline, Up to 10 minutes

Study Arms (1)

Buffered Anesthetic Side/Non-buffered Anesthetic Side

EXPERIMENTAL

Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.

Drug: Non-buffered Anesthetic; Drug: Buffered Anesthetic; Device: Onset

Interventions

Non-buffered Anesthetic DRUG

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

Buffered Anesthetic Side/Non-buffered Anesthetic Side

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.

Buffered Anesthetic Side/Non-buffered Anesthetic Side

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.

Buffered Anesthetic Side/Non-buffered Anesthetic Side

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (2)

Dental Clinic of Rainbow Center for Women and Children

Cleveland, Ohio, 44103, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ying An
• Organization: University Hospitals Cleveland Medical Center

Ying.An@UHhospitals.org

(216)368-3277

Study Officials

• Ying An, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Participant and Care provider is blinded as to which side is buffered and which is non-buffered
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients serve as their own control. One side of the mouth is buffered, one side is non-buffered

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: December 8, 2020
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)