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NCT Number: NCT01546090

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

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.

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Key information

Conditions

Inferior Alveolar Nerve Block Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alprazolam

Drug

preoperative administration of an orally 0.50 mg single dose

Other names: xanax, Pfizer

Placebo

Drug

placebo capsules were filled with starch

Other names: starch

Primary outcomes

  1. the success rate of the IAN block

    Time frame: one hour after administration of alprazolam

Secondary outcomes

  1. initial pain

    Time frame: one hour after administration of alprazolam

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Collaborators

  • University of Isfahan

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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