Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Ketorolac Tromethamine; Acetaminophen; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 10 mg Ketorolac tromethamine is applied 45 minutes before the injection.; 10 mg Ketorolac tromethamine/ 1000mg Acetaminophen application before injection.; This group receive the caplet including placebo 45 minutes before the injection.
Other intervention name(s): Toradol; non
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Failure; Injection; Ketorolac; Premedication