Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen
- Conditions
- NSAID
- Sponsor
- University of Washington
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Andrew Keith
Principal Investigator
University of Washington
Eligibility Criteria
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
Arms & Interventions
Acetaminophen
Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
Intervention: Acetaminophen
Ibuprofen
Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Intervention: Ibuprofen
Acetaminophen and Ibuprofen
Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Intervention: Acetaminophen
Acetaminophen and Ibuprofen
Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
Intervention: Ibuprofen
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
Time Frame: 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
Time Frame: 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
Time Frame: 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."