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Status unknownNCT02940405Updated Oct 21, 2016

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

An interventional study of Ketorolac Tromethamine and Placebo in Irreversible Pulpitis, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-10-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Irreversible Pulpitis

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Keywords

  • Ketorolac Premedication
  • Anesthetic Efficiency
  • Post-Endodontic Pain
  • Post-operative pain
  • Irreversible Pulpitis
  • Oral premedication
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's planned enrollment of 38 is below the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    ketorolac tromethamine

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

    Drug: Ketorolac Tromethamine

  • Placebo comparator
    placebo tablet

    One tablet of a placebo one hour before endodontic treatment

    Drug: Placebo

Interventions

  • DrugKetorolac Tromethamine

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

    Also known as: ketolac, toradol

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Anesthetic efficiency

    Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.

    Time frame: Intraoperative (During endodontic treatment)

Secondary outcomes

  1. Postoperative pain

    Postoperative pain will be measured using a numerical rating scale (NRS)

    Time frame: At 6,12, 24, 48 hours after root canal treatment

  2. Number of patients requiring rescue analgesic.

    Number of patients requiring rescue analgesic within 48 hours after endodontic treatment

    Time frame: Within 48 hours after endodontic treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 27042580 ↗
  • 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. PubMed 20171350 ↗
  • 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. PubMed 25506136 ↗
  • 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. PubMed 23716973 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02940405
Lead sponsor
Cairo University
Responsible party
Laila Zakaria Ismail (Resident at endodontic departement , Faculty of Oral and Dental medicine ,Cairo University, Cairo University) — Principal investigator
First posted
Oct 20, 2016
Start date
Jan 2017
Primary completion
Oct 2017 (estimated)
Completion
Jan 2018 (estimated)
Last update
Oct 21, 2016

Study contacts

Laila Z Ismail, Postgraduate
Contact
Laila.zakaria@dentistry.cu.edu.eg
+002 (01223487628)
Suzan AW Amin, PhD
Contact
swanees@rockmail.com
Laila Z Ismail, Postgraduate
principal investigator · Cairo University
Suzan AW Amin, PhD
study chair · Cairo University
Salsabeel M Ibrahim, Professor
study director · Cairo University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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