Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection

NCT05473819 | Unknown DMC

• 1 other identifier: 2890
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Local Anesthesia

Keywords

buffered; sodium bicarbonate; inferior alveolar nerve block; pain; pulpotomy; articaine

Outcome Measures

Primary Outcomes (1)

• Pain during inferior alveolar nerve block injection

  Sound, Eye, Motor (SEM) Scale (Appendix II), will be used as an objective method for pain assessment. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated by the operator using the recorded video tapes. The slightest manifestations of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1 (comfort), 2 (mild discomfort), 3 (moderate discomfort), and 4 (severe discomfort), respectively. SEM score will be calculated by summing the three grades of the parameters

  during local anesthesia administration

Secondary Outcomes (1)

• the onset time of the Anaesthesia

  after local anesthesia administration

Other Outcomes (1)

• the effectiveness of the anaesthesia

  after local anesthesia administration

Study Arms (2)

Buffered Anaesthetic solution

EXPERIMENTAL

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

Drug: Buffered Local Anesthesia

Conventional Anaesthetic solution

ACTIVE COMPARATOR

4% Articaine HCL with 1:1000000 epinephrine Anaesthetic carpule

Drug: Conventional Unbuffered Local Anesthesia

Interventions

Buffered Local Anesthesia 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.

Buffered Anaesthetic solution

Conventional Unbuffered Local Anesthesia DRUG

The control group will receive the unbuffered conventional anaesthetic solution

Conventional Anaesthetic solution

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Kholoud Mamdouh Ahmed Nour

Alexandria, 00203, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split Mouth Design

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 26, 2022
• Study Start: May 15, 2022
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-01

Locations

EG (1)