Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

NCT02923687 | Completed Phase 2 DMC

• 1 other identifier: AZadUMS-P/190/D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of this study is to evaluate premedication with ketorolac infiltration on post endodontic pain in patients with symptomatic irreversible pulpitis. Design: Randomized double blind clinical trial Setting and conduct: Sixty adult volunteers with including criteria will be divided into two groups (n=30) based on random table. All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes one group will receive supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline. Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test. The pain level will be recorded immediately and at the 2,4,6 and 24 hours following the treatment using Heft- Parker Visual Analog Scale (HP- VAS). Data will be evaluated using Repeated measured test (if possible) and otherwise non-parametric tests such as rival Friedman and X2 test. Participants including major eligibility criteria: all patients age ranged 18-65 with symptomatic irreversible pulpitis (HP VAS ≥54) and without pain on percussion on a mandibular molar tooth who need root canal treatment and are without systemic diseases; nonsmoking; non pregnant, non breast feeding without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration Main outcome measures: Pain level at immediately after the treatment, 2, 4, 6 and 24 hours following the root canal treatment using HP VAS.

Conditions

Irreversible Pulpitis

Keywords

Ketorolac; Root canal treatment; Pain; Premedication

Outcome Measures

Primary Outcomes (1)

• Premedication effect of Ketorolac buccal infiltration on post Endodontic pain

  The pain level after the root canal therapy will be recorded using HP-VAS up to 24 hours in each of the case and control groups and will be compared.

  24 hours

Study Arms (2)

Buccal infiltration of Ketorolac

ACTIVE COMPARATOR

All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, case group will receive a supplemental buccal infiltration of 30 mg/mL of Ketorolac tromethamine (Alborz-Darou Co. Qazvin, Iran).

Drug: Ketorolac Tromethamine

Buccal infiltration of Normal saline

PLACEBO COMPARATOR

All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, the control group will receive normal saline as placebo.

Drug: Placebo

Interventions

Ketorolac Tromethamine DRUG

All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, the experimental group will receive supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine.

Also known as: Tradol Alborz-Darou Co. Qazvin, Iran

Buccal infiltration of Ketorolac

Placebo DRUG

All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, control group will receive 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 without apical periodontitis that needs root canal treatment.

You may not qualify if:

• The patients less than 18 and more than 65 years old;
• systemic diseases;
• any medicine consumption;
• smoking;
• pregnant;
• breast feeding;
• apical periodontitis.

Sponsors & Collaborators

• Azad University of Medical Sciences: lead

Study Sites (1)

Dental Branch, AZad UMS

Tehran, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Ketorolac Tromethamine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)