Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block

Study Overview
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Brief Summary
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The purpose of this prospective, randomized, double-blind, placebo-controlled study is to evaluate the effect of preoperative administration of alprazolam on the success of the IAN block for teeth with irreversible pulpitis.

Detailed Description
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Sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly receive, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional IAN block. Access is begun 15 minutes after completion of the IAN block, and all patients profound lip numbness. Success is defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.

Official Title
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Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis

Conditions
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Inferior Alveolar Nerve Block Failure

Intervention / Treatment
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* Drug: Alprazolam
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with active pain in a mandibular molar prolonged response to cold testing with Endo-Frost cold spray Absence of any periapical radiolucency on radiographs a vital pulp while access cavity preparation ability to understand the use of pain scales. Exclusion Criteria: patients were having allergy and sensitivity to benzodiazepines pregnant and breast feeding patients patients who had taken sedation within 24 hours before the treatment having pain in more than one mandibular tooth unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: alprazolam<br>Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs | Drug: Alprazolam<br>* preoperative administration of an orally 0.50 mg single dose<br>* Other names: xanax, Pfizer;|
| Placebo Comparator: placebo<br>placebo capsules were filled with starch | Drug: placebo<br>* placebo capsules were filled with starch<br>* Other names: starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the success rate of the IAN block |  | one hour after administration of alprazolam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial pain |  | one hour after administration of alprazolam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alprazolam, benzodiazepines, Inferior alveolar nerve block, irreversible pulpitis, local anesthesia