Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis
NCT ID: NCT02940405
Last Updated: 2016-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
38 participants
INTERVENTIONAL
2017-01-31
2018-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ketorolac tromethamine
One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment
Ketorolac Tromethamine
A 10 mg tablet of the medication will be given one hour before starting the root canal treatment
placebo tablet
One tablet of a placebo one hour before endodontic treatment
Placebo
The placebo given as a tablet one hour before staring the root canal treatment
Interventions
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Ketorolac Tromethamine
A 10 mg tablet of the medication will be given one hour before starting the root canal treatment
Placebo
The placebo given as a tablet one hour before staring the root canal treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males or Females.
3. Mandibular Posterior teeth with symptomatic irreversible pulpitis.
4. Patients with non-contributory systemic condition.
Exclusion Criteria
2. Pregnant females
3. If analgesics have been administrated during the past 8 hours before endodontic treatment.
4. Irrestorable teeth.
18 Years
45 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Laila Zakaria Ismail
Resident at endodontic departement , Faculty of Oral and Dental medicine ,Cairo University
Principal Investigators
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Laila Z Ismail, Postgraduate
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Suzan AW Amin, PhD
Role: STUDY_CHAIR
Cairo University
Salsabeel M Ibrahim, Professor
Role: STUDY_DIRECTOR
Cairo University
Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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CEBC-CU-2016-10-148
Identifier Type: -
Identifier Source: org_study_id
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