Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection

NCT ID: NCT05473819

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-09-01

Brief Summary

This study will test the effectiveness of addition of Sodium Bicarbonate as a buffering agent to the anaesthetic solution on minimizing the pain of injection and increasing the onset time and potency of the anaesthetic solution in children

Detailed Description

27 healthy cooperative children will be enrolled in the study after taking their guardians' informed consent.

The study design will be a split mouth design where each patient will be received buffered anaesthetic solution (8.4% sodium bicarbonate will be added to the anaesthetic solution in ratio 1:19) in one side and conventional anaesthetic solution (4% articaine HCL with 1:1000000 epinephrine) in the other side.

The pain during injection for each patient in both sides will be then compared using objective and subjective methods.

The onset time of the anaesthesia in both sides will also be compared for each patient using Transcutaneous electric nerve stimulator device (TENS)

The results will be collected and mentioned.

Conditions

Local Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Buffered Anaesthetic solution

8.4% sodium bicarbonate will be added to the 4% articaine HCL with 1:1000000 epinephrine carpule in ratio 19:1 the Articaine to the Sodium bicarbonate

Group Type: EXPERIMENTAL

Buffered Local Anesthesia

Intervention Type: DRUG

Buffered local anesthesia will be administered after being previously prepared just before the injection time.

Buffering Local Anesthetic Solutions Using 8.4% Sodium Bicarbonate in a 19:1 Ratio: Using the "REMOVE AND REPLACE hand buffering method"

-Under sterile conditions, 0.09 mL of local anesthetic solution will be removed from the cartridge using a 0.5 mL syringe with a 28- gauge, 0.5-inch needle (Kendall Monoject Insulin Syringe [Tyco Healthcare, tyco.com] lot number 027501). Using a separate unused syringe, 0.09 mL of the commercially available 8.4% sodium bicarbonate will be removed from the 50 mL vial and immediately injected into the local anesthetic cartridge. The cartridge will be inverted 5 times to mix the solution, and no precipitation will be present.

Conventional Anaesthetic solution

4% Articaine HCL with 1:1000000 epinephrine Anaesthetic carpule

Group Type: ACTIVE_COMPARATOR

Conventional Unbuffered Local Anesthesia

Intervention Type: DRUG

The control group will receive the unbuffered conventional anaesthetic solution

Interventions

Buffered Local Anesthesia

Buffered local anesthesia will be administered after being previously prepared just before the injection time.

Buffering Local Anesthetic Solutions Using 8.4% Sodium Bicarbonate in a 19:1 Ratio: Using the "REMOVE AND REPLACE hand buffering method"

-Under sterile conditions, 0.09 mL of local anesthetic solution will be removed from the cartridge using a 0.5 mL syringe with a 28- gauge, 0.5-inch needle (Kendall Monoject Insulin Syringe [Tyco Healthcare, tyco.com] lot number 027501). Using a separate unused syringe, 0.09 mL of the commercially available 8.4% sodium bicarbonate will be removed from the 50 mL vial and immediately injected into the local anesthetic cartridge. The cartridge will be inverted 5 times to mix the solution, and no precipitation will be present.

Intervention Type: DRUG

Conventional Unbuffered Local Anesthesia

The control group will receive the unbuffered conventional anaesthetic solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age range from 5 - 7 years.
• Children free of any systemic disease or special health care need (ASA I).
• No previous bad dental experience.
• Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
• Patients whom their lower primary molars bilaterally are indicated for pulpotomy.
• Patients whom their parents will give consent to participate.
• Patients who give multiple reliable responses while using the transcutaneous electric nerve stimulator device.

Exclusion Criteria

• Active sites of pathosis in area of injection that could affect anaesthetic assessment.
• History of allergy to local anaesthesia.
• Root resorption affecting more than one third of the root length.
• Fractured crowns due to trauma.
• Clinical signs and symptoms of pulp degeneration such as swelling or sinus tracts
• Radiographic evidence of periapical or interradicular radiolucency
• Non restorable crowns.
• Signs of mobility.
• Ankylosed roots.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kholoud Mamdouh Ahmed Nour

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

2890

Identifier Type: -

Identifier Source: org_study_id