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

Phase 4

Completed

• Conditions: Inferior Alveolar Nerve Block Failure
• Interventions: Drug: placebo; Drug: Alprazolam

• Registration Number: NCT01546090
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-10
• Study Completion: 2012-02
• Status Verified: 2012-03
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-06
• Last Update Submitted: 2012-03-06
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo capsules were filled with starch
alprazolam	Alprazolam	Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs

Primary Outcome Measures

Name	Time	Method
the success rate of the IAN block	one hour after administration of alprazolam

Secondary Outcome Measures

Name	Time	Method
initial pain	one hour after administration of alprazolam

Trial Locations

Locations (1)

School of Dentistry, Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of