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

NCT02536430 | Completed Phase 2 DMC

• 1 other identifier: AZadUMS-P/212/D
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed Mechanical Induction

Keywords

Infra alveolar nerve block; Ketorolac; Success rate

Outcome Measures

Primary Outcomes (1)

• Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block

  One week

Study Arms (2)

Buccal infiltration of Ketorolac

ACTIVE COMPARATOR

A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.

Drug: Ketorolac Tromethamine

buccal infiltration of Normal Saline

PLACEBO COMPARATOR

A buccal infiltration of Normal Saline was applied for the patients in control group.

Drug: Placebo

Interventions

Ketorolac Tromethamine DRUG

One group received a buccal infiltration of Ketorolac Tromethamine

Also known as: Toradol

Buccal infiltration of Ketorolac

Placebo DRUG

buccal infiltration of Normal Saline.

Also known as: Normal Saline

buccal infiltration of Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Nahid Mohammadzadeh Akhlaghi: lead

Study Sites (1)

Dental Branch, AZad UMS

Tehran, Tehran Province, Iran

Location

MeSH Terms

Interventions

Ketorolac Tromethamine; Saline Solution

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nahid Mohammadzadeh Akhlaghi, DDS,MDS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor Nahid Mohammadzadeh Akhlaghi

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 31, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

IR (1)