Pre-emptive Analgesics in Orthodontic Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment

Conditions
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NSAID, Pain Management

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients of the University of Washington Graduate Orthodontics Clinic
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen<br>Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment | Drug: Acetaminophen<br>* Acetaminophen gel capsule<br>* Other names: Paracetamol;|
| Active Comparator: Ibuprofen<br>Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment | Drug: Ibuprofen<br>* Ibuprofen gel capsule<br>* Other names: Advil;|
| Experimental: Acetaminophen and Ibuprofen<br>Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment | Drug: Acetaminophen<br>* Acetaminophen gel capsule<br>* Other names: Paracetamol;Drug: Ibuprofen<br>* Ibuprofen gel capsule<br>* Other names: Advil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 hours after orthodontic treatment | 
| 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. | 1 day after orthodontic treatment | 
| 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. | 2 days after orthodontic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-emptive analgesics, Acetaminophen, Ibuprofen