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

October 28, 2020 updated by: Sovana Tarek, Cairo University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diclofenac potassium- acetaminophen combination
Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
Drug: Diclofenac potassium- acetaminophen combination
Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
EXPERIMENTAL: Diclofenac potassium
Preoperative single dose of diclofenac potassium(50mg)
Drug: Diclofenac potassium
Preoperative single dose of diclofenac potassium(50mg)
PLACEBO_COMPARATOR: Placebo
Preoperative single dose of placebo
Drug: Placebo
Preoperative single dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic success of inferior alveolar nerve block
Time Frame: During the treatment
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-ENDO-6-10-2020.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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