Clinical trial NCT05473819: Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection
Official title: Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Inferior Alveolar Nerve Block in Children : a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Local Anesthesia
Keywords: buffered
sodium bicarbonate
inferior alveolar nerve block
pain
pulpotomy
articaine
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split Mouth Design
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain during inferior alveolar nerve block injection
timeFrame: during local anesthesia administration
Secondary outcomes:
measure: the onset time of the Anaesthesia
timeFrame: after local anesthesia administration
Other outcomes:
measure: the effectiveness of the anaesthesia
timeFrame: after local anesthesia administration
Locations:
city: Alexandria
country: Egypt
facility: Kholoud Mamdouh Ahmed Nour
Study officials:
References: