Trial Outcomes & Findings for Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy (NCT NCT03631433)

NCT ID: NCT03631433

Last Updated: 2021-05-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 102 participants
• Primary outcome timeframe: 4 day postoperative survey
• Results posted on: 2021-05-04

Participant Flow

Participant milestones

Measure	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. Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen	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. ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen
Overall Study STARTED	49	53
Overall Study COMPLETED	49	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ibuprofen n=49 Participants 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. Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen	Ibuprofen/Acetaminophen n=53 Participants 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. ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=49 Participants	0 Participants n=53 Participants	0 Participants n=102 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=49 Participants	53 Participants n=53 Participants	102 Participants n=102 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants	0 Participants n=53 Participants	0 Participants n=102 Participants
Age, Continuous	34 years STANDARD_DEVIATION 11 • n=49 Participants	35 years STANDARD_DEVIATION 12 • n=53 Participants	34 years STANDARD_DEVIATION 11 • n=102 Participants
Sex: Female, Male Female	29 Participants n=49 Participants	39 Participants n=53 Participants	68 Participants n=102 Participants
Sex: Female, Male Male	20 Participants n=49 Participants	14 Participants n=53 Participants	34 Participants n=102 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	49 Participants n=49 Participants	53 Participants n=53 Participants	102 Participants n=102 Participants
pain level on a Heft-Parker VAS	129 units on a scale STANDARD_DEVIATION 22 • n=49 Participants	128 units on a scale STANDARD_DEVIATION 23 • n=53 Participants	128 units on a scale STANDARD_DEVIATION 22 • n=102 Participants

PRIMARY outcome

Timeframe: 4 day postoperative survey

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

Outcome measures

Measure	Ibuprofen n=49 Participants 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. Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen	Ibuprofen/Acetaminophen Combination n=53 Participants 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. ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen
Heft Parker Visual Analog Scale Pain Scale Pain Measurements	63 units on a scale Standard Deviation 41	60 units on a scale Standard Deviation 42

PRIMARY outcome

Timeframe: 4 day postoperative survey

Number of participants requiring escape pills

Outcome measures

Measure	Ibuprofen n=49 Participants 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. Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen	Ibuprofen/Acetaminophen Combination n=53 Participants 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. ibuprofen 600 mg and acetaminophen 650 mg: identical appearing tablets of the combination of ibuprofen and acetaminophen
Number of Participants	20 Participants	18 Participants

Adverse Events

Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ibuprofen/Acetaminophen Combination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Melissa Drum

OSU

Phone: 6142923596

Email: drum.13@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place