Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain

September 17, 2016 updated by: Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain

The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers with age ranged 18-65, non smoking or any medicine consumption, non pregnant or break feeding who haven't received any analgesic during 24 hours before the treatment, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before the treatment. All patients will receive a standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) with no need to take analgesic during 6, 12, 24 and 48 hours intervals following the treatment. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with age ranged 18-65
  • without systemic diseases
  • without any medicine consumption
  • non smoking
  • non pregnant
  • non breast feeding
  • with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment
  • without any medicine consumption or analgesic and sedation who understand and sign the VAS and consent forms.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketorolac tromethanine
10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment
Drug: Ketorolac tromethamine
10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment
Other Names:
  • Toradol
Active Comparator: Acetaminphen & Ketorolac tromethamine
1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment
Drug: Ketorolac tromethamine
10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment
Other Names:
  • Toradol
Drug: Acetaminophen
1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.
Other Names:
  • Tylenol
Placebo Comparator: Placebo
placebo 45 minutes before root canal treatment
Drug: Placebo
placebo 45 minutes before root canal treatment
Other Names:
  • disambiguation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rate change based on visual analog scale(VAS) form
Time Frame: 6,12,24,and 48 hour intervals
Each patient receives a VAS form and record his/her pain rate on the VAS form whenever he/she feels any pain during each interval after the treatment. If the patient has to take any analgesic, she/he will record the pain rate on that interval and will not continue filling the forms out on the next intervals.
6,12,24,and 48 hour intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azad University of Medical Sciences

Investigators

  • Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS,MDS, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 17, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZadUMS-P/139/D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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