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

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ClinicalTrials.gov Identifier: NCT03631433
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ohio State University

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ibuprofen 600 mg Drug: ibuprofen 600 mg and acetaminophen 650 mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: identical appearing tablets and random allocation
Primary Purpose: Treatment
Official Title: An Evaluation of Postoperative Pain Using Ibuprofen Versus Ibuprofen/Acetaminophen in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Actual Study Start Date : February 10, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ibuprofen
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.
Drug: Ibuprofen 600 mg
identical appearing tablets containing 600 mg of ibuprofen

Experimental: ibuprofen/acetaminophen combination
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.
Drug: ibuprofen 600 mg and acetaminophen 650 mg
identical appearing tablets of the combination of ibuprofen and acetaminophen




Primary Outcome Measures :
  1. Heft Parker Visual Analog Scale pain scale pain measurements [ Time Frame: 4 day postoperative survey ]
    Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome.

  2. pain medication pill count [ Time Frame: 4 day postoperative survey ]
    number of tabs taken



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:   No
Criteria

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

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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT03631433     History of Changes
Other Study ID Numbers: 2015H0433
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Ibuprofen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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