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

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ketorolac tromethamine
Acetaminophen
Placebo
Sponsored by
Azad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Irreversible Pulpitis focused on measuring Endodontic treatment, non steroid, pain, pre medication

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Dental Branch, AZad UMS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ketorolac tromethanine

Acetaminphen & Ketorolac tromethamine

Placebo

Arm Description

10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment

1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment

placebo 45 minutes before root canal treatment

Outcomes

Primary Outcome Measures

Pain rate change based on visual analog scale(VAS) form
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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2015
Last Updated
September 17, 2016
Sponsor
Azad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02614118
Brief Title
Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain
Official Title
Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
Endodontic treatment, non steroid, pain, pre medication

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac tromethanine
Arm Type
Active Comparator
Arm Description
10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment
Arm Title
Acetaminphen & Ketorolac tromethamine
Arm Type
Active Comparator
Arm Description
1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 45 minutes before root canal treatment
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine
Other Intervention Name(s)
Toradol
Intervention Description
10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
disambiguation
Intervention Description
placebo 45 minutes before root canal treatment
Primary Outcome Measure Information:
Title
Pain rate change based on visual analog scale(VAS) form
Description
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.
Time Frame
6,12,24,and 48 hour intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahid Mohammadzadeh Akhlaghi, DDS,MDS
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Branch, AZad UMS
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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