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

Primary Purpose

Irreversible Pulpitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Ketorolac Premedication, Anesthetic Efficiency, Post-Endodontic Pain, Post-operative pain, Irreversible Pulpitis, Oral premedication

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ketorolac tromethamine

    placebo tablet

    Arm Description

    One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment

    One tablet of a placebo one hour before endodontic treatment

    Outcomes

    Primary Outcome Measures

    Anesthetic efficiency
    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

    Postoperative pain
    Postoperative pain will be measured using a numerical rating scale (NRS)
    Number of patients requiring rescue analgesic.
    Number of patients requiring rescue analgesic within 48 hours after endodontic treatment

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    October 20, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02940405
    Brief Title
    Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irreversible Pulpitis
    Keywords
    Ketorolac Premedication, Anesthetic Efficiency, Post-Endodontic Pain, Post-operative pain, Irreversible Pulpitis, Oral premedication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ketorolac tromethamine
    Arm Type
    Experimental
    Arm Description
    One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment
    Arm Title
    placebo tablet
    Arm Type
    Placebo Comparator
    Arm Description
    One tablet of a placebo one hour before endodontic treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac Tromethamine
    Other Intervention Name(s)
    ketolac, toradol
    Intervention Description
    A 10 mg tablet of the medication will be given one hour before starting the root canal treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    The placebo given as a tablet one hour before staring the root canal treatment
    Primary Outcome Measure Information:
    Title
    Anesthetic efficiency
    Description
    Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.
    Time Frame
    Intraoperative (During endodontic treatment)
    Secondary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    Postoperative pain will be measured using a numerical rating scale (NRS)
    Time Frame
    At 6,12, 24, 48 hours after root canal treatment
    Title
    Number of patients requiring rescue analgesic.
    Description
    Number of patients requiring rescue analgesic within 48 hours after endodontic treatment
    Time Frame
    Within 48 hours after endodontic treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18-45 years old. Males or Females. Mandibular Posterior teeth with symptomatic irreversible pulpitis. Patients with non-contributory systemic condition. Exclusion Criteria: Patients allergic to any analgesics or antibiotics or anesthetics Pregnant females If analgesics have been administrated during the past 8 hours before endodontic treatment. Irrestorable teeth.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laila Z Ismail, Postgraduate
    Phone
    +002 (01223487628)
    Email
    Laila.zakaria@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzan AW Amin, PhD
    Email
    swanees@rockmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laila Z Ismail, Postgraduate
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Suzan AW Amin, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Salsabeel M Ibrahim, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27042580
    Citation
    Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.
    Results Reference
    background
    PubMed Identifier
    20171350
    Citation
    Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.
    Results Reference
    background
    PubMed Identifier
    25506136
    Citation
    Sethi P, Agarwal M, Chourasia HR, Singh MP. Effect of single dose pretreatment analgesia with three different analgesics on postoperative endodontic pain: A randomized clinical trial. J Conserv Dent. 2014 Nov;17(6):517-21. doi: 10.4103/0972-0707.144574.
    Results Reference
    background
    PubMed Identifier
    23716973
    Citation
    Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
    Results Reference
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    Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis

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