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Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

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 treatment trial for Irreversible Pulpitis focused on measuring Failure, Injection, Ketorolac, Premedication

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
  • 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

Acetaminophen

Placebo

Arm Description

This group will receive a caplet including10 mg Ketorolac tromethamine 45 minutes before applying infra alveolar nerve block injection.

This group receive a caplet including10 mg Ketorolac tromethamine/ 1000 mg Acetaminophen, before applying the injection.

This group receive a caplet including placebo, before applying the injection.

Outcomes

Primary Outcome Measures

Pain rate using Visual Analog Scale (VAS) form
Pain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2015
Last Updated
September 17, 2016
Sponsor
Azad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02601911
Brief Title
Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection
Official Title
Comparison of Ketorolac and Ketorolac/Acetaminophen on Success of Inferior Alveolar Nerve Block Injection
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
June 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 effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers including criteria, 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 applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection . Patients with no lip numbness and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.
Detailed Description
The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers with including criteria and with no spontaneous pain, reporting no or mild (Visual analog scale≤54) pain in response to cold testing and electric pulp tester, are participating. The patients will be divided into 3 groups on a random basis and will be randomly given one of the oral 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 Inferior Alveolar Nerve Block injection with one carpule of 4% Articaine with 1:100000 Epinephrine. Patients with no anesthetic sign (lip numbness) and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. 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
Failure, Injection, Ketorolac, Premedication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac tromethanine
Arm Type
Active Comparator
Arm Description
This group will receive a caplet including10 mg Ketorolac tromethamine 45 minutes before applying infra alveolar nerve block injection.
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
This group receive a caplet including10 mg Ketorolac tromethamine/ 1000 mg Acetaminophen, before applying the injection.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group receive a caplet including placebo, before applying the injection.
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Other Intervention Name(s)
Toradol
Intervention Description
10 mg Ketorolac tromethamine is applied 45 minutes before the injection.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
non
Intervention Description
10 mg Ketorolac tromethamine/ 1000mg Acetaminophen application before injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
This group receive the caplet including placebo 45 minutes before the injection.
Primary Outcome Measure Information:
Title
Pain rate using Visual Analog Scale (VAS) form
Description
Pain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form.
Time Frame
45 minutes

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 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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Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

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