ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 434 for:    KETOROLAC
Previous Study | Return to List | Next Study

Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02536430
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Condition or disease Intervention/treatment Phase
Failed Mechanical Induction Drug: Ketorolac Tromethamine Drug: Placebo Phase 2

Detailed Description:

Objectives:

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.

Design: Randomized double blind clinical trial

Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration

Main outcome measures : Pain during caries and dentin removal , access cavity preparation and canals length measurements using VAS.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial
Study Start Date : March 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Buccal infiltration of Ketorolac
A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.
 Drug: Ketorolac Tromethamine
One group received a buccal infiltration of Ketorolac Tromethamine
Other Name: Toradol
Placebo Comparator: buccal infiltration of Normal Saline
A buccal infiltration of Normal Saline was applied for the patients in control group.
 Drug: Placebo
buccal infiltration of Normal Saline.
Other Name: Normal Saline


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block [ Time Frame: One week ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with age ranged 18-65;
  • without systemic diseases;
  • without any medicine consumption;
  • non smoking;
  • non pregnant;
  • non breast feeding;
  • with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular molar that needs root canal treatment

Exclusion Criteria:

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536430


Locations
Iran, Islamic Republic of
Dental Branch, AZad UMS
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Nahid Mohammadzadeh Akhlaghi
Investigators
Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS,MDS Associate Professor
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nahid Mohammadzadeh Akhlaghi, Doctor Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02536430     History of Changes
Other Study ID Numbers: AZadUMS-P/212/D
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences:
Infra alveolar nerve block
Ketorolac
Success rate

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action