NCT02923687

Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Azad University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2016-10-04
• Last updated: 2019-01-15

Locations

1 site across 1 country: Iran