Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Drug: Placebo; Drug: Diclofenac Potassium 50mg Tab.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dentistry Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amatallah H Al-Rawhani, Pos, Faculty of Oral and Dental Medicine/ Cairo University.

Publications and helpful links

General Publications

• Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.
• Metri M, Hegde S, Bhandi S. Effect of pretreatment diclofenac sodium on postendodontic pain: A randomised controlled trial. J Conserv Dent. 2016 Jan-Feb;19(1):7-10. doi: 10.4103/0972-0707.173183.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative pain; Pulpitis, irreversible Pulpitis,; Diclofenac Potassium; Premedication, Preoperative Analgesic
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: CEBC-CU-2016-11-167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No