NSAID, Pain Management
Conditions
Keywords
Pre-emptive analgesics, Acetaminophen, Ibuprofen
Brief summary
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.
Detailed description
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and while chewing paraffin wax during the following time intervals: immediately following drug administration, 6 hours after, the morning after, and the second morning after orthodontic treatment.
Interventions
DRUGAcetaminophen
Acetaminophen gel capsule
DRUGIbuprofen
Ibuprofen gel capsule
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The medications were prepared by the Kelley-Ross Compounding Group (Seattle, WA) and were identical in appearance. The bottles were labeled as A, B, or C and the identity of the medications were not revealed until after the data analysis was completed.
Intervention model description
Patients of the University of Washington Graduate Orthodontics Clinic
Eligibility
Sex/Gender
ALL
Age
12 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
-Orthodontic patient presenting for orthodontic treatment
Exclusion criteria
* History of taking an analgesic in the past six hours * Hypersensitivity to ibuprofen or acetaminophen * Aspirin-sensitive asthma * Renal or liver impairment * History of GI bleeding or ulcers * Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery * Currently taking antibiotics or other medications for a chronic systemic disease * Bleeding disorder * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | 6 hours after orthodontic treatment | Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain. |
| Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | 1 day after orthodontic treatment | Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain. |
| Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | 2 days after orthodontic treatment | Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain. |
Countries
United States
Participant flow
Recruitment details
Orthodontic patients that presented to the University of Washington Graduate Orthodontics Clinic between May 2nd and June 23rd, 2017 were approached for recruitment.
Pre-assignment details
Participants were screened against a set of inclusion criteria during the informed consent process. If one or more of the inclusion were not met then the patient was not assigned to a group.
Participants by arm
| Arm | Count |
|---|---|
| Acetaminophen Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
Acetaminophen: Acetaminophen gel capsule | 7 |
| Ibuprofen Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Ibuprofen: Ibuprofen gel capsule | 8 |
| Acetaminophen and Ibuprofen Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Acetaminophen: Acetaminophen gel capsule
Ibuprofen: Ibuprofen gel capsule | 7 |
| Total | 22 |
Baseline characteristics
| Characteristic | Acetaminophen | Ibuprofen | Acetaminophen and Ibuprofen | Total |
|---|---|---|---|---|
| Age, Continuous | 21.7 years STANDARD_DEVIATION 9.6 | 25.9 years STANDARD_DEVIATION 18 | 21.4 years STANDARD_DEVIATION 15.3 | 23.1 years STANDARD_DEVIATION 14.3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 7 participants | 8 participants | 7 participants | 22 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 1 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 25 |
Outcome results
Primary
Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment
Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain.
Time frame: 1 day after orthodontic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Biting | 2.9 scores on a scale | Standard Deviation 2.5 |
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Rest | 1.9 scores on a scale | Standard Deviation 2.5 |
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Chewing | 3.6 scores on a scale | Standard Deviation 2.8 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Biting | 2.5 scores on a scale | Standard Deviation 2.1 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Rest | 2.0 scores on a scale | Standard Deviation 1.7 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Chewing | 3.9 scores on a scale | Standard Deviation 3.1 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Rest | 1.1 scores on a scale | Standard Deviation 1.2 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Chewing | 2.7 scores on a scale | Standard Deviation 1.7 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment | Biting | 2.1 scores on a scale | Standard Deviation 2.7 |
p-value: 0.65ANOVA
p-value: 0.82ANOVA
p-value: 0.69ANOVA
Primary
Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment
Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain.
Time frame: 2 days after orthodontic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Biting | 2.3 scores on a scale | Standard Deviation 2.9 |
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Rest | 1.3 scores on a scale | Standard Deviation 2.6 |
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Chewing | 2.9 scores on a scale | Standard Deviation 2.9 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Biting | 2.3 scores on a scale | Standard Deviation 1.5 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Rest | 1.4 scores on a scale | Standard Deviation 1.5 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Chewing | 3.1 scores on a scale | Standard Deviation 2 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Rest | 0.4 scores on a scale | Standard Deviation 0.5 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Chewing | 1.6 scores on a scale | Standard Deviation 1.4 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment | Biting | 0.9 scores on a scale | Standard Deviation 1.1 |
p-value: 0.53ANOVA
p-value: 0.31ANOVA
p-value: 0.37ANOVA
Primary
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain.
Time frame: 6 hours after orthodontic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Biting | 2.0 scores on a scale | Standard Deviation 1.4 |
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Rest | 0.6 scores on a scale | Standard Deviation 0.8 |
| Acetaminophen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Chewing | 2.3 scores on a scale | Standard Deviation 1.4 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Biting | 2.9 scores on a scale | Standard Deviation 2.5 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Rest | 2.6 scores on a scale | Standard Deviation 2.2 |
| Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Chewing | 4.0 scores on a scale | Standard Deviation 3.1 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Rest | 1.0 scores on a scale | Standard Deviation 1 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Chewing | 3.1 scores on a scale | Standard Deviation 2.5 |
| Acetaminophen and Ibuprofen | Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment | Biting | 2.0 scores on a scale | Standard Deviation 1.9 |
p-value: 0.04ANOVA
p-value: 0.63ANOVA
p-value: 0.41ANOVA