Clinical trial NCT02923687: Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
Official title: Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irreversible Pulpitis
Keywords: Ketorolac
Root canal treatment
Pain
Premedication
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility 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 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.

Primary outcomes:
measure: Premedication effect of Ketorolac buccal infiltration on post Endodontic pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dental Branch, AZad UMS
Study officials:
affiliation: Associate Professor
name: Nahid Mohammadzadeh Akhlaghi, DDS,MDS
role: STUDY_CHAIR
References: