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

NCT ID: NCT02940405

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irreversible Pulpitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ketorolac tromethamine

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

Group Type EXPERIMENTAL

Ketorolac Tromethamine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo given as a tablet one hour before staring the root canal treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac Tromethamine

A 10 mg tablet of the medication will be given one hour before starting the root canal treatment

Intervention Type DRUG

Placebo

The placebo given as a tablet one hour before staring the root canal treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ketolac, toradol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laila Zakaria Ismail

Resident at endodontic departement , Faculty of Oral and Dental medicine ,Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Reach out to these primary contacts for questions about participation or study logistics.

Laila Z Ismail, Postgraduate

Role: CONTACT

+002 (01223487628)

Suzan AW Amin, PhD

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27042580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20171350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25506136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23716973 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEBC-CU-2016-10-148

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.