Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |