Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.

Detailed Description
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Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.

Official Title
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Effect of Preoperative, Single-dose Diclofenac Potassium on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Controlled Trial

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Drug: Diclofenac Potassium 50mg Tab.
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with active pain (moderate-to-severe) in mandibular molars. Patients with prolonged response to cold testing and electric pulp tester. Patient with the ability to understand and use pain scales. Patient with vital coronal pulp tissue on access. Patient who accept to enroll to the study. Exclusion Criteria: Patients' allergies or any other contraindication to diclofenac potassium or articaine. Pregnant and lactating females. Patients having pain medication in the last 6 hours. Patient has more than one symptomatic mandibular tooth in the same quadrant. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. Patients with active peptic ulcer and gastrointestinal disorders. Patients with history of bleeding problems or anticoagulant use within the last month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomly divided into 2 groups: Experimental group: 50 mg Diclofenac Potassium to be administered one hour before treatment. Control group: Placebo to be administered one hour before treatment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Potassium 50mg tab<br>Diclofenac Potassium 50mg tablet to be administered one hour before treatment. | Drug: Diclofenac Potassium 50mg Tab.<br>* A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.<br>|
| Placebo Comparator: Placebo<br>Placebo to be administered one hour before treatment. | Drug: Placebo<br>* A placebo will be taken one hour before initiation of endodontic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative endodontic pain | Pain after completion root canal treatment measured by Heft-parker visual analogue scale. | Up to 2 days after endodontic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic intake | The incidence of analgesic intake is recorded | Up to 2 days after endodontic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpitis, irreversible Pulpitis,, Diclofenac Potassium, Premedication, Preoperative Analgesic, Postoperative pain