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

Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02940405
• Other study ID #: CEBC-CU-2016-10-148
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: October 20, 2016
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Laila Z Ismail, Postgraduate
• Phone: +002 (01223487628)
• Email: Laila.zakaria[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis
• Toothache

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthetic efficiency	Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.	Intraoperative (During endodontic treatment)	No
Secondary	Postoperative pain	Postoperative pain will be measured using a numerical rating scale (NRS)	At 6,12, 24, 48 hours after root canal treatment	No
Secondary	Number of patients requiring rescue analgesic.	Number of patients requiring rescue analgesic within 48 hours after endodontic treatment	Within 48 hours after endodontic treatment	No