Pain, Postoperative
Conditions
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.
Interventions
DRUGIbuprofen 600 mg
identical appearing tablets containing 600 mg of ibuprofen
DRUGibuprofen 600 mg and acetaminophen 650 mg
identical appearing tablets of the combination of ibuprofen and acetaminophen
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
identical appearing tablets and random allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heft Parker Visual Analog Scale Pain Scale Pain Measurements | 4 day postoperative survey | Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome. |
| Number of Participants | 4 day postoperative survey | Number of participants requiring escape pills |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| Ibuprofen/Acetaminophen 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 | 53 |
| Total | 102 |
Baseline characteristics
| Characteristic | Ibuprofen | Ibuprofen/Acetaminophen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 53 Participants | 102 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 12 | 34 years STANDARD_DEVIATION 11 |
| pain level on a Heft-Parker VAS | 129 units on a scale STANDARD_DEVIATION 22 | 128 units on a scale STANDARD_DEVIATION 23 | 128 units on a scale STANDARD_DEVIATION 22 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 49 Participants | 53 Participants | 102 Participants |
| Sex: Female, Male Female | 29 Participants | 39 Participants | 68 Participants |
| Sex: Female, Male Male | 20 Participants | 14 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 49 | 0 / 53 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Heft Parker Visual Analog Scale Pain Scale Pain Measurements
Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome.
Time frame: 4 day postoperative survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | Heft Parker Visual Analog Scale Pain Scale Pain Measurements | 63 units on a scale | Standard Deviation 41 |
| Ibuprofen/Acetaminophen Combination | Heft Parker Visual Analog Scale Pain Scale Pain Measurements | 60 units on a scale | Standard Deviation 42 |
Primary
Number of Participants
Number of participants requiring escape pills
Time frame: 4 day postoperative survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen | Number of Participants | 20 Participants |
| Ibuprofen/Acetaminophen Combination | Number of Participants | 18 Participants |