Phase 4
N=102
Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03631433 ↗Enrolled (actual)
102
Serious AEs
—
Results posted
May 2021
Primary outcome: Primary: Heft Parker Visual Analog Scale Pain Scale Pain Measurements — 63; 60 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibuprofen 600 mg (Drug); ibuprofen 600 mg and acetaminophen 650 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heft Parker Visual Analog Scale Pain Scale Pain Measurements |
63; 60 | — |
| PRIMARY Number of Participants |
20; 18 | — |
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.
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)
- 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
Data sourced from ClinicalTrials.gov (NCT03631433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.