NCT02940405

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

October 19, 2016

Last Update Submit

October 20, 2016

Conditions

Irreversible Pulpitis

Keywords

Ketorolac PremedicationAnesthetic EfficiencyPost-Endodontic PainPost-operative painIrreversible PulpitisOral premedication

Outcome Measures

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.

    Intraoperative (During endodontic treatment)

Secondary Outcomes (2)

  • Postoperative pain

    At 6,12, 24, 48 hours after root canal treatment

  • Number of patients requiring rescue analgesic.

    Within 48 hours after endodontic treatment

Study Arms (2)

ketorolac tromethamine

EXPERIMENTAL

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

Drug: Ketorolac Tromethamine

placebo tablet

PLACEBO COMPARATOR

One tablet of a placebo one hour before endodontic treatment

Drug: Placebo

Interventions

Ketorolac TromethamineDRUG

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

Also known as: ketolac, toradol
ketorolac tromethamine
PlaceboDRUG

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

placebo tablet

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-45 years old.
  • Males or Females.
  • Mandibular Posterior teeth with symptomatic irreversible pulpitis.
  • Patients with non-contributory systemic condition.

You may not qualify if:

  • Patients allergic to any analgesics or antibiotics or anesthetics
  • Pregnant females
  • If analgesics have been administrated during the past 8 hours before endodontic treatment.
  • Irrestorable teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 27042580BACKGROUND

  • 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.

    PMID: 20171350BACKGROUND

  • 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.

    PMID: 25506136BACKGROUND

  • 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.

    PMID: 23716973BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Laila Z Ismail, Postgraduate

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Suzan AW Amin, PhD

    Cairo University

    STUDY CHAIR

  • Salsabeel M Ibrahim, Professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Laila Z Ismail, Postgraduate

CONTACT

+002 (01223487628)Laila.zakaria@dentistry.cu.edu.eg

Suzan AW Amin, PhD

CONTACT

swanees@rockmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at endodontic departement , Faculty of Oral and Dental medicine ,Cairo University

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 20, 2016

Study Start

January 1, 2017

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share