Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection

Alexandria University

Status: Unknown

Conditions: Local Anesthesia

Treatments: Drug: Buffered Local Anesthesia; Drug: Conventional Unbuffered Local Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05473819

2890

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

27 participants in 2 patient groups

Buffered Anaesthetic solution

Experimental group

Description:

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

Treatment:

Drug: Buffered Local Anesthesia

Conventional Anaesthetic solution

Active Comparator group

Description:

4% Articaine HCL with 1:1000000 epinephrine Anaesthetic carpule

Treatment:

Drug: Conventional Unbuffered Local Anesthesia