Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

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- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients 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 diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

Official Title
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Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: Diclofenac potassium- acetaminophen combination
* Drug: Diclofenac potassium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic irreversible pulpitis with/without mechanical allodynia Patients with moderato to severe spontaneous pain Mandibular molars Patients with the ability to understand and use the pain scale Patients accepting enrollment in the study Exclusion Criteria: Patients allergic to any medication or material to be used in the study Pregnant and lactating females Patients taking medications affecting pain perception in the last 12 hours Patients having more than one symptomatic molar in the same quadrant Patients with contributory medical history (ASA > II)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac potassium- acetaminophen combination<br>Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination | Drug: Diclofenac potassium- acetaminophen combination<br>* Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination<br>|
| Experimental: Diclofenac potassium<br>Preoperative single dose of diclofenac potassium(50mg) | Drug: Diclofenac potassium<br>* Preoperative single dose of diclofenac potassium(50mg)<br>|
| Placebo Comparator: Placebo<br>Preoperative single dose of placebo | Drug: Placebo<br>* Preoperative single dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic success of inferior alveolar nerve block | Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain. Success will be defined as no to mild pain. | During the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain at 6 hours | Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain | 6 hours | 
| Postoperative pain at 12 hours | Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain | 12 hours | 
| Postoperative pain at 24 hours | represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain | 24 hours | 
| Postoperative pain at 48 hours | represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain | 48 hours | 
| Postoperative pain at 72 hours | represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain | 72 hours | 
| Postoperative pain at 7 days | represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain 0: reading represents no pain 1-3 : readings represent mild pain 4-6 : readings represent moderate pain 7-10 : readings represent severe pain | 7 days |