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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Irreversible Pulpitis||Drug: Ketorolac Tromethamine Drug: Placebo||Not Applicable|
- 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 (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
The placebo given as a tablet one hour before staring the root canal treatment
- 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.
- 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)
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02940405
|Contact: Laila Z Ismail, Postgraduate||+002 (01223487628)||Laila.email@example.com|
|Contact: Suzan AW Amin, PhDfirstname.lastname@example.org|
|Principal Investigator:||Laila Z Ismail, Postgraduate||Cairo University|
|Study Chair:||Suzan AW Amin, PhD||Cairo University|
|Study Director:||Salsabeel M Ibrahim, Professor||Cairo University|