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

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ClinicalTrials.gov Identifier: NCT01546090
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
University of Isfahan
Information provided by (Responsible Party):
Masoud Saatchi, 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.

Condition or disease Intervention/treatment Phase
Inferior Alveolar Nerve Block Failure Drug: Alprazolam Drug: placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2011
Primary Completion Date : October 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

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

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 Name: xanax, Pfizer
Placebo Comparator: placebo
placebo capsules were filled with starch
Drug: placebo
placebo capsules were filled with starch
Other Name: starch



Primary Outcome Measures :
  1. the success rate of the IAN block [ Time Frame: one hour after administration of alprazolam ]

Secondary Outcome Measures :
  1. initial pain [ Time Frame: one hour after administration of alprazolam ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546090


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

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 ( Other Identifier: School of Dentistry )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Masoud Saatchi, 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
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action