MedPath

Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

Phase 2
Completed
Conditions
Irreversible Pulpitis
Interventions
Registration Number
NCT02601911
Lead Sponsor
Azad University of Medical Sciences
Brief Summary

The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection . Patients with no lip numbness and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Detailed Description

The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers with including criteria and with no spontaneous pain, reporting no or mild (Visual analog scale≤54) pain in response to cold testing and electric pulp tester, are participating. The patients will be divided into 3 groups on a random basis and will be randomly given one of the oral medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection with one carpule of 4% Articaine with 1:100000 Epinephrine. Patients with no anesthetic sign (lip numbness) and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Patients with age ranged 18-65
  • without systemic diseases
  • without any medicine consumption
  • non smoking
  • non pregnant
  • non breast feeding
  • with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment
  • without any medicine consumption or analgesic and sedation
  • understand and sign the VAS and consent forms
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboThis group receive a caplet including placebo, before applying the injection.
Ketorolac tromethanineKetorolac TromethamineThis group will receive a caplet including10 mg Ketorolac tromethamine 45 minutes before applying infra alveolar nerve block injection.
AcetaminophenAcetaminophenThis group receive a caplet including10 mg Ketorolac tromethamine/ 1000 mg Acetaminophen, before applying the injection.
Primary Outcome Measures
NameTimeMethod
Pain rate using Visual Analog Scale (VAS) form45 minutes

Pain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dental Branch, AZad UMS

🇮🇷

Tehran, Iran, Islamic Republic of

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