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

March 6, 2012 updated by: Masoud Saatchi, Isfahan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of, 8174673461
        • School of Dentistry, Isfahan University of Medical Sciences
      • Isfahan, Iran, Islamic Republic of, 81747673461
        • School of Dentistry, Isfahan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: alprazolam
Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs
Drug: Alprazolam
preoperative administration of an orally 0.50 mg single dose
Other Names:
  • xanax, Pfizer
PLACEBO_COMPARATOR: placebo
placebo capsules were filled with starch
Drug: placebo
placebo capsules were filled with starch
Other Names:
  • starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the success rate of the IAN block
Time Frame: one hour after administration of alprazolam
one hour after administration of alprazolam

Secondary Outcome Measures

Outcome Measure
Time Frame
initial pain
Time Frame: one hour after administration of alprazolam
one hour after administration of alprazolam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Collaborators

University of Isfahan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390553 (OTHER: School of Dentistry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inferior Alveolar Nerve Block Failure

Clinical Trials on Alprazolam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe