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Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

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ClinicalTrials.gov Identifier: NCT02923687
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE September 29, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
Premedication effect of Ketorolac buccal infiltration on post Endodontic pain [ Time Frame: 24 hours ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02923687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
Official Title  ICMJE Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Irreversible Pulpitis
Intervention  ICMJE
  • 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.
    Other Name: Tradol Alborz-Darou Co. Qazvin, Iran
  • 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.
    Other Name: Normal saline
Study Arms  ICMJE
  • Active Comparator: Buccal infiltration of Ketorolac
    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).
    Intervention: Drug: Ketorolac Tromethamine
  • Placebo Comparator: Buccal infiltration of Normal saline
    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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02923687
Other Study ID Numbers  ICMJE AZadUMS-P/190/D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences
Study Sponsor  ICMJE Azad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nahid Mohammadzadeh Akhlaghi, DDS,MDS Associate Professor
PRS Account Azad University of Medical Sciences
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP