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

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Inferior Alveolar Nerve Block Failure

Treatments: Drug: Alprazolam; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01546090

390553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

alprazolam

Experimental group

Description:

Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs

Treatment:

Drug: Alprazolam

placebo

Placebo Comparator group

Description:

placebo capsules were filled with starch

Treatment:

Drug: placebo