Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

Irreversible Pulpitis Clinical Trial

Official title:

Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923687
• Other study ID #: AZadUMS-P/190/D
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: January 2019
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Endodontic treatment of all the patients will be performed in a single visit, using crown down method and with rotary instrumentation till master apical file size# 30.06. 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: The pain level immediately and at the 2, 4, 6 and 24 hours following the treatment using HP- VAS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 without apical periodontitis that needs root canal treatment.

Exclusion Criteria:

• The patients less than 18 and more than 65 years old;

• systemic diseases;

• any medicine consumption;

• smoking;

• pregnant;

• breast feeding;

• apical periodontitis.

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Drug:
• Ketorolac Tromethamine
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.
• Placebo
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental Branch, AZad UMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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