Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Inferior Alveolar Nerve Block in Children : a Randomised Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Buffered Local Anesthesia
- Conditions
- Local Anesthesia
- Sponsor
- Alexandria University
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Pain during inferior alveolar nerve block injection
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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
Intervention: Buffered Local Anesthesia
Conventional Anaesthetic solution
4% Articaine HCL with 1:1000000 epinephrine Anaesthetic carpule
Intervention: Conventional Unbuffered Local Anesthesia
Outcomes
Primary Outcomes
Pain during inferior alveolar nerve block injection
Time Frame: during local anesthesia administration
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
Secondary Outcomes
- the onset time of the Anaesthesia(after local anesthesia administration)