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

Tracking Information
First Received Date ^ICMJE	March 2, 2012
Last Updated Date	March 6, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2012)	the success rate of the IAN block [ Time Frame: one hour after administration of alprazolam ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01546090 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2012)	initial pain [ Time Frame: one hour after administration of alprazolam ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
Official Title ^ICMJE	Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis
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.
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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Inferior Alveolar Nerve Block Failure
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	February 2012
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01546090
Other Study ID Numbers ^ICMJE	390553, 390553, 390553
Has Data Monitoring Committee	Yes
Responsible Party	Masoud Saatchi, Isfahan University of Medical Sciences
Study Sponsor ^ICMJE	Isfahan University of Medical Sciences
Collaborators ^ICMJE	Isfahan University School of Dentistry
Investigators ^ICMJE	Not Provided
Information Provided By	Isfahan University of Medical Sciences
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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