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

NCT03631433 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2015H0433
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Heft Parker Visual Analog Scale Pain Scale Pain Measurements

  Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome.

  4 day postoperative survey

• Number of Participants

  Number of participants requiring escape pills

  4 day postoperative survey

Study Arms (2)

ibuprofen

ACTIVE COMPARATOR

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

ibuprofen/acetaminophen combination

EXPERIMENTAL

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

Interventions

Ibuprofen 600 mg DRUG

identical appearing tablets containing 600 mg of ibuprofen

ibuprofen

ibuprofen 600 mg and acetaminophen 650 mg DRUG

identical appearing tablets of the combination of ibuprofen and acetaminophen

ibuprofen/acetaminophen combination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Melissa Drum
• Organization: OSU

drum.13@osu.edu

6142923596

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: identical appearing tablets and random allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 15, 2018
• Study Start: February 10, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 17, 2017
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share