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Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ibuprofen 600 mg
ibuprofen 600 mg and acetaminophen 650 mg
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. mandibular (bottom) or maxillary (top) posterior (back) tooth requiring root canal treatment
  2. mandibular (bottom) or maxillary (top) posterior (back) tooth with symptomatic irreversible pulpitis and symptomatic apical periodontitis (painful tooth to cold and biting)

2. between the ages of 18 and 65 years of age 3. American Society of Anesthesiologist classification I

Exclusion Criteria:

  1. patients younger than 18 or older than 65 years of age
  2. American Society of Anesthesiologist classification II or higher
  3. allergies or contraindications to ibuprofen
  4. allergies or contraindications to acetaminophen
  5. pregnancy
  6. inability to give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    ibuprofen

    ibuprofen/acetaminophen combination

    Arm Description

    A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.

    A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.

    Outcomes

    Primary Outcome Measures

    Heft Parker Visual Analog Scale Pain Scale Pain Measurements
    Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome.
    Number of Participants
    Number of participants requiring escape pills

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2018
    Last Updated
    April 9, 2021
    Sponsor
    Ohio State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03631433
    Brief Title
    Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy
    Official Title
    An Evaluation of Postoperative Pain Using Ibuprofen Versus Ibuprofen/Acetaminophen in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 10, 2016 (Actual)
    Primary Completion Date
    May 1, 2017 (Actual)
    Study Completion Date
    July 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ohio State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim: The purpose of this study was to compare ibuprofen versus an ibuprofen/acetaminophen combination for postoperative pain control in patients requiring root canal treatment with a tooth that is painful to cold and biting. Methodology: Following regular root canal treatment, patients randomly received identical appearing tablets of 600 mg ibuprofen or 600 mg ibuprofen/650 mg acetaminophen to be taken every 6 hours as needed for pain. A 4-day diary was used to record pain and medication use.
    Detailed Description
    This was a single-center, double-blind, interventional trial where (randomly) one group received ibuprofen and the other group received ibuprofen and acetaminophen. Before the experiment, the ibuprofen and ibuprofen/acetaminophen groups were assigned 6-digit random numbers. The number assignment determined which drug regimen would be administered postoperatively for each patient. Only the random numbers were recorded on the data collection sheet in order to maintain blinding of the experiment. The blinding of the ibuprofen and ibuprofen/acetaminophen medications was done as follows. A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). The pharmacist prepared the master code sheet and assigned the random numbers to the bottles. Therefore, the medication was blind to both the patient and the operator. A copy of the master list of random numbers was supplied by the compounding pharmacist solely to the lead researcher and was not made available to anyone else during the data collection period. At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain. The patients received a diary for 4 days post-treatment to record pain, percussion pain, and the amount and type of study medications taken. Patients were instructed to tap on the tooth that had emergency endodontic treatment and record this as their percussion pain. Patients recorded their pain levels on a VAS as described earlier for postoperative treatment pain. Starting on the morning after their appointment, patients also recorded the number of study medications taken within each 24-hour period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    identical appearing tablets and random allocation
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ibuprofen
    Arm Type
    Active Comparator
    Arm Description
    A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.
    Arm Title
    ibuprofen/acetaminophen combination
    Arm Type
    Experimental
    Arm Description
    A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.
    Intervention Type
    Drug
    Intervention Name(s)
    Ibuprofen 600 mg
    Intervention Description
    identical appearing tablets containing 600 mg of ibuprofen
    Intervention Type
    Drug
    Intervention Name(s)
    ibuprofen 600 mg and acetaminophen 650 mg
    Intervention Description
    identical appearing tablets of the combination of ibuprofen and acetaminophen
    Primary Outcome Measure Information:
    Title
    Heft Parker Visual Analog Scale Pain Scale Pain Measurements
    Description
    Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome.
    Time Frame
    4 day postoperative survey
    Title
    Number of Participants
    Description
    Number of participants requiring escape pills
    Time Frame
    4 day postoperative survey

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: mandibular (bottom) or maxillary (top) posterior (back) tooth requiring root canal treatment mandibular (bottom) or maxillary (top) posterior (back) tooth with symptomatic irreversible pulpitis and symptomatic apical periodontitis (painful tooth to cold and biting) 2. between the ages of 18 and 65 years of age 3. American Society of Anesthesiologist classification I Exclusion Criteria: patients younger than 18 or older than 65 years of age American Society of Anesthesiologist classification II or higher allergies or contraindications to ibuprofen allergies or contraindications to acetaminophen pregnancy inability to give informed consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy

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