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Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection

NCT05473819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-07-26

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2022-06-01
Completion
2022-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473819 on ClinicalTrials.gov