NCT05473819

Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection

Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Inferior Alveolar Nerve Block in Children : a Randomised Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Conventional Unbuffered Local Anesthesia	The control group will receive the unbuffered conventional anaesthetic solution

Timeline

• Start date: 2022-05-15
• Primary completion: 2022-06-01
• Completion: 2022-09-01
• First posted: 2022-07-26
• Last updated: 2022-07-26

Locations

1 site across 1 country: Egypt