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Trial record 40 of 475 for:    KETOROLAC

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02940405
Recruitment Status : Unknown
Verified October 2016 by Laila Zakaria Ismail, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Laila Zakaria Ismail, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Drug: Ketorolac Tromethamine Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

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 Name: 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02940405

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Contact: Laila Z Ismail, Postgraduate +002 (01223487628)
Contact: Suzan AW Amin, PhD

Sponsors and Collaborators
Cairo University
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Principal Investigator: Laila Z Ismail, Postgraduate Cairo University
Study Chair: Suzan AW Amin, PhD Cairo University
Study Director: Salsabeel M Ibrahim, Professor Cairo University

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Responsible Party: Laila Zakaria Ismail, Resident at endodontic departement , Faculty of Oral and Dental medicine ,Cairo University, Cairo University Identifier: NCT02940405     History of Changes
Other Study ID Numbers: CEBC-CU-2016-10-148
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Laila Zakaria Ismail, Cairo University:
Ketorolac Premedication
Anesthetic Efficiency
Post-Endodontic Pain
Post-operative pain
Irreversible Pulpitis
Oral premedication
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action