Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

Comparative Evaluation of Adding Dexamethasone to 2% Lidocaine (With and Without Epinephrine) on the Anesthetic Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

This randomized, double-blind clinical trial aimed at the evaluation of the effect of adding dexamethasone to 2% lidocaine, given as inferior alveolar nerve block in the endodontic management of symptomatic irreversible pulpitis. One hundred and twenty four patients received one of the three IANB injections before the endodontic treatment: 2% lidocaine with 1:80 000 epinephrine; 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone; and plain 2% lidocaine mixed with 2mg dexamethasone. The anesthetia was considered successful if the patients experienced no pain or faint/weak/mild pain during root canal access preparation and instrumentation (HP VAS score <55 mm). The effect of intraligamentary injections on maximum heart rates was also recorded.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Drug: Lidocaine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110025
    • Faculty of Dentistry, Jamia MIliia Islamia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
• active pain in a mandibular molar
• prolonged response to cold testing with an ice stick and an electric pulp tester
• vital coronal pulp on access opening and ability to understand the use of pain scales

Exclusion Criteria:

• a history of known or suspected drug abuse
• history of active peptic ulcer within the preceding 12 months
• history of bleeding problems or anticoagulant use within the last month
• known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
• patients who had taken NSAIDs within 12 h before administration of the study drugs
• patients who were pregnant or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine; An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine	Drug: Lidocaine Hydrochloride; Inferior alveolar nerve block; Other Names: dexamethasone
Experimental: Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone; An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone	Drug: Lidocaine Hydrochloride; Inferior alveolar nerve block; Other Names: dexamethasone
Experimental: Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone; An Inferior Alveolar nerve block was given with plain 2% lidocaine mixed with 2mg dexamethasone	Drug: Lidocaine Hydrochloride; Inferior alveolar nerve block; Other Names: dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthtic success	Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.	15 minutes after the inferior alveolar nerve block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	The effect of injections on maximum heart rates was recorded.	After 1 minutes of initial injection

Collaborators and Investigators

• Sponsor: Jamia Millia Islamia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexamethasone; Lidocaine
• Other Study ID Numbers: Dexamethasone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: Immediately after publication
• IPD Sharing Access Criteria: Immediately after publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No