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

October 20, 2016 updated by: Laila Zakaria Ismail, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

38

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.

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-45 years old.
  2. Males or Females.
  3. Mandibular Posterior teeth with symptomatic irreversible pulpitis.
  4. Patients with non-contributory systemic condition.

Exclusion Criteria:

  1. Patients allergic to any analgesics or antibiotics or anesthetics
  2. Pregnant females
  3. If analgesics have been administrated during the past 8 hours before endodontic treatment.
  4. Irrestorable teeth.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic efficiency
Time Frame: Intraoperative (During endodontic treatment)
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
Time Frame: At 6,12, 24, 48 hours after root canal treatment
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.
Time Frame: Within 48 hours after endodontic treatment
Number of patients requiring rescue analgesic within 48 hours after endodontic treatment
Within 48 hours after endodontic treatment

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Laila Z Ismail, Postgraduate, Cairo University
  • Study Director: Salsabeel M Ibrahim, Professor, 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

January 1, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2016-10-148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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