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Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain

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ClinicalTrials.gov Identifier: NCT02614118
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Brief Summary:
The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Drug: Ketorolac tromethamine Drug: Acetaminophen Drug: Placebo Phase 2

Detailed Description:
The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers with age ranged 18-65, non smoking or any medicine consumption, non pregnant or break feeding who haven't received any analgesic during 24 hours before the treatment, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before the treatment. All patients will receive a standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) with no need to take analgesic during 6, 12, 24 and 48 hours intervals following the treatment. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain
Study Start Date : September 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketorolac tromethanine
10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment
Drug: Ketorolac tromethamine
10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment
Other Name: Toradol

Active Comparator: Acetaminphen & Ketorolac tromethamine
1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment
Drug: Ketorolac tromethamine
10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment
Other Name: Toradol

Drug: Acetaminophen
1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.
Other Name: Tylenol

Placebo Comparator: Placebo
placebo 45 minutes before root canal treatment
Drug: Placebo
placebo 45 minutes before root canal treatment
Other Name: disambiguation




Primary Outcome Measures :
  1. Pain rate change based on visual analog scale(VAS) form [ Time Frame: 6,12,24,and 48 hour intervals ]
    Each patient receives a VAS form and record his/her pain rate on the VAS form whenever he/she feels any pain during each interval after the treatment. If the patient has to take any analgesic, she/he will record the pain rate on that interval and will not continue filling the forms out on the next intervals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with age ranged 18-65
  • without systemic diseases
  • without any medicine consumption
  • non smoking
  • non pregnant
  • non breast feeding
  • with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment
  • without any medicine consumption or analgesic and sedation who understand and sign the VAS and consent forms.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614118


Locations
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Iran, Islamic Republic of
Dental Branch, AZad UMS
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Azad University of Medical Sciences
Investigators
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Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS,MDS Associate Professor

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Responsible Party: Nahid Mohammadzadeh Akhlaghi, Associate Professor, Azad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02614118     History of Changes
Other Study ID Numbers: AZadUMS-P/139/D
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences:
Endodontic treatment
non steroid
pain
pre medication

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action