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

March 2, 2012
March 6, 2012
March 2011
October 2011   (final data collection date for primary outcome measure)
the success rate of the IAN block [ Time Frame: one hour after administration of alprazolam ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01546090 on ClinicalTrials.gov Archive Site
initial pain [ Time Frame: one hour after administration of alprazolam ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inferior Alveolar Nerve Block Failure
  • Drug: Alprazolam
    preoperative administration of an orally 0.50 mg single dose
    Other Name: xanax, Pfizer
  • Drug: placebo
    placebo capsules were filled with starch
    Other Name: starch
  • Experimental: alprazolam
    Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs
    Intervention: Drug: Alprazolam
  • Placebo Comparator: placebo
    placebo capsules were filled with starch
    Intervention: Drug: placebo
Lindemann M, Reader A, Nusstein J, Drum M, Beck M. Effect of sublingual triazolam on the success of inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2008 Oct;34(10):1167-70. Epub 2008 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01546090
390553, 390553, 390553
Yes
Masoud Saatchi, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Isfahan University School of Dentistry
Not Provided
Isfahan University of Medical Sciences
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP