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

This study has been completed.
Sponsor:
Collaborator:
Isfahan University School of Dentistry
Information provided by (Responsible Party):
Masoud Saatchi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01546090
First received: March 2, 2012
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Inferior Alveolar Nerve Block Failure
 Drug: Alprazolam
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis

Resource links provided by NLM:

Drug Information available for: Alprazolam
U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • the success rate of the IAN block [ Time Frame: one hour after administration of alprazolam ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • initial pain [ Time Frame: one hour after administration of alprazolam ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: xanax, Pfizer
Placebo Comparator: placebo
placebo capsules were filled with starch
 Drug: placebo
placebo capsules were filled with starch
Other Name: starch

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546090

Locations
Iran, Islamic Republic of
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of, 81747673461
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of, 8174673461
Sponsors and Collaborators
Isfahan University of Medical Sciences
Isfahan University School of Dentistry
  More Information

Publications:

Responsible Party: Masoud Saatchi, Associate Professor of Endodontics, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01546090     History of Changes
Other Study ID Numbers: 390553, 390553, 390553
Study First Received: March 2, 2012
Last Updated: March 6, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Alprazolam
benzodiazepines
Inferior alveolar nerve block
irreversible pulpitis
local anesthesia

Additional relevant MeSH terms:
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013