Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis
Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Local Anesthesia
Intervention: Lidocaine (Drug); sodium bicarbonate (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Masoud Saatchi Official(s) and/or principal investigator(s):
Masoud Saatchi, DDS MSc, Study Chair, Affiliation: Isfahan University of Medical Sciences
Summary
Buffering of local anesthetics (alkalinization) has been suggested in achieving pain
control. The purpose of this prospective, randomized, double-blind study was to evaluate the
effect of adding 0. 6 mL 8. 4% sodium bicarbonate to 3. 0 mL 2% lidocaine with 1: 80,000
epinephrine on the success rate of IAN block for endodontic treatment of mandibular molars
with symptomatic irreversible pulpitis.
Clinical Details
Official title: Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of Inferior Alveolar Nerve Block for Teeth With Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Percentage of the success of IAN Block anesthesia with a buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Secondary outcome: Heft-Parker visual analog scale recording of a non-buffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve block
Detailed description:
Some studies have been shown buffering of local anesthetics reduce pain of injection, hasten
the onset of anesthesia, and improved success rate of anesthesia. Others reported buffering
of local anesthetics cannot reduce pain of injection, hasten the onset of anesthesia, and
improve success rate of anesthesia. There are no studies evaluating a sodium
bicarbonate-buffered lidocaine formulation for IAN block for teeth with irreversible
pulpitis.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Exclusion Criteria:
- younger than 18 years old
- history of significant medical conditions
- allergies to local anesthetics or sulfites
- pregnancy
- taking any medications that might influence anesthetic assessment
- active sites of pathosis in area of injection
- inability to give informed consent
Locations and Contacts
Additional Information
Starting date: February 2013
Last updated: August 25, 2014
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