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

Not Applicable

• Conditions: Irreversible Pulpitis
• Interventions: Drug: Placebo; Drug: Ketorolac Tromethamine

• Registration Number: NCT02940405
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21
• Study Start: 2017-01
• Primary Completion: 2017-10
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo tablet	Placebo	One tablet of a placebo one hour before endodontic treatment
ketorolac tromethamine	Ketorolac Tromethamine	One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment

Primary Outcome Measures

Name	Time	Method
Anesthetic efficiency	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

Name	Time	Method
Postoperative pain	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.	Within 48 hours after endodontic treatment	Number of patients requiring rescue analgesic within 48 hours after endodontic treatment