Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): Ketorolac Tromethamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Tradol Alborz-Darou Co. Qazvin, Iran; Normal saline
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ketorolac; Root canal treatment; Pain; Premedication