Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis

Study Overview
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Brief Summary
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The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis.

Detailed Description
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Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit. Patients will be randomly assigned to one of 2 groups: experimental group (taking a 10 mg tablet of ketorolac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. The patient's pain will be assessed before local anesthetic adminstration. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated. During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated. Postoperative pain will be assessed 6, 12, 24 and 48 hours after treatment. The number of patients who will require rescue analgesic medication within the 48 hours postoperatively will be counted.

Official Title
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Effect of Ketorolac Premedication on Anesthetic Efficiency of Inferior Alveolar Nerve Block, Pre-Treatment and Post-Endodontic Pain in Teeth With Irreversible Pulpitis: A Randomized Controlled Double Blinded Trial

Conditions
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Irreversible Pulpitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-45 years old. Males or Females. Mandibular Posterior teeth with symptomatic irreversible pulpitis. Patients with non-contributory systemic condition. Exclusion Criteria: Patients allergic to any analgesics or antibiotics or anesthetics Pregnant females If analgesics have been administrated during the past 8 hours before endodontic treatment. Irrestorable teeth.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketorolac tromethamine<br>One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment | Drug: Ketorolac Tromethamine<br>* A 10 mg tablet of the medication will be given one hour before starting the root canal treatment<br>* Other names: ketolac, toradol;|
| Placebo Comparator: placebo tablet<br>One tablet of a placebo one hour before endodontic treatment | Drug: Placebo<br>* The placebo given as a tablet one hour before staring the root canal treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic efficiency | Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success. | Intraoperative (During endodontic treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be measured using a numerical rating scale (NRS) | At 6,12, 24, 48 hours after root canal treatment | 
| Number of patients requiring rescue analgesic. | Number of patients requiring rescue analgesic within 48 hours after endodontic treatment | Within 48 hours after endodontic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketorolac Premedication, Anesthetic Efficiency, Post-Endodontic Pain, Post-operative pain, Irreversible Pulpitis, Oral premedication