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Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

Purpose

The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.

Condition

Pain, Orofacial

Eligibility

Eligible Ages: Between 12 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch); - extractions, if required, performed at least 2 weeks before appliance and archwire placement; - healthy with no significant medical findings; - no prophylactic antibiotic coverage required; - currently not taking antibiotics or analgesics; - no contraindications to the use of acetaminophen or ibuprofen; and - minimum age of 12 years

Exclusion Criteria

Under the age of 12 or over the age of 80, - prisoners, - pregnant women, - decisionally challenged individuals, - allergy to either medication, - history of kidney disease, - liver damage or disease, - alcoholism/use of 3 or more alcoholic drinks during study period, - use of blood thinners, - stomach ulcers or - stomach bleeding.

Study Design

Phase: Early Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two investigational groups and a placebo group
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Ibuprofen, acetaminophen and placebo tablets have been prepared to look identical by a pharmacy. The appropriate tablets are placed in a blister pack to be delivered to the study participant. The number of tablets are the same for each blister in all blister packs. The study participant, care provider, investigators and the outcomes assessor are all blinded to the groups.

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Ibuprofen	one 200 mg tablet of ibuprofen and 2 placebo tablets	Drug: Ibuprofen 200 mg and acetaminphen 650 mg For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively. Drug: Ibuprofen 200 mg For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.
Experimental Ibuprofen and acetaminophen	one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen	Drug: Ibuprofen 200 mg and acetaminphen 650 mg For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.
Placebo Comparator Placebo	3 tablets of tableting compounds with no active ingredients	Drug: Placebo oral tablet For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.

Recruiting Locations

University of Colorado, School of Dental Medicine
Aurora, Colorado 80045

Contact:
Clifton Carey, PhD
303-724-1046
clifton.carey@ucdenver.edu

More Details

NCT ID: NCT04059172
Status: Recruiting
Sponsor: University of Colorado, Denver

Study Contact

Clifton M Carey, PhD
3037241046
clifton.carey@cuanschutz.edu

Detailed Description

Orthodontic pain is often reported for the first 4 days after the appliances are attached. This study will investigate two modes of pain management versus a placebo. Consented subjects will be randomly assigned to one of 3 groups: Group A, a combined and simultaneous therapy of 200 mg ibuprofen and 650 mg acetaminophen (3 pills total) taken orally at set time intervals (0 h, 6 h, 12 h, and 24h, 48h, 72h, and 96h); Group B, ibuprofen alone (200 mg) taken orally at same time intervals (1 ibuprofen and 2 placebo pills); Group C, placebo taken orally at the same time intervals (3 placebo pills). The study will be blinded for the investigators, patients, and statisticians.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.