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

• Sponsor: Nahid Mohammadzadeh Akhlaghi
• Information provided by (Responsible Party): Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Study Description

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

• 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

Arms and Interventions

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

Primary Outcome Measures :

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

Eligibility Criteria

• 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

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

• 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
• 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