Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Ketorolac and Ketorolac/Acetaminophen on Success of Inferior Alveolar Nerve Block Injection

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Drug: Ketorolac Tromethamine
* Drug: Acetaminophen
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac tromethanine<br>This group will receive a caplet including10 mg Ketorolac tromethamine 45 minutes before applying infra alveolar nerve block injection. | Drug: Ketorolac Tromethamine<br>* 10 mg Ketorolac tromethamine is applied 45 minutes before the injection.<br>* Other names: Toradol;|
| Active Comparator: Acetaminophen<br>This group receive a caplet including10 mg Ketorolac tromethamine/ 1000 mg Acetaminophen, before applying the injection. | Drug: Acetaminophen<br>* 10 mg Ketorolac tromethamine/ 1000mg Acetaminophen application before injection.<br>* Other names: non;|
| Placebo Comparator: Placebo<br>This group receive a caplet including placebo, before applying the injection. | Other: Placebo<br>* This group receive the caplet including placebo 45 minutes before the injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rate using Visual Analog Scale (VAS) form | Pain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form. | 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Failure, Injection, Ketorolac, Premedication