Clinical trial NCT02940405: Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: Ketorolac Premedication
Anesthetic Efficiency
Post-Endodontic Pain
Post-operative pain
Irreversible Pulpitis
Oral premedication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anesthetic efficiency
timeFrame: Intraoperative (During endodontic treatment)
Secondary outcomes:
measure: Postoperative pain
timeFrame: At 6,12, 24, 48 hours after root canal treatment
measure: Number of patients requiring rescue analgesic.
timeFrame: Within 48 hours after endodontic treatment
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Laila Z Ismail, Postgraduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Suzan AW Amin, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Salsabeel M Ibrahim, Professor
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.