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

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Early Phase 1

Conditions: Pain, Orofacial

Treatments: Drug: Ibuprofen 200 mg; Drug: Ibuprofen 200 mg and acetaminphen 650 mg; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04059172

17-1449

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 12 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 3 patient groups, including a placebo group

Ibuprofen

Active Comparator group

Description:

one 200 mg tablet of ibuprofen and 2 placebo tablets

Treatment:

Drug: Ibuprofen 200 mg

Ibuprofen and acetaminophen

Experimental group

Description:

one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen

Treatment:

Drug: Ibuprofen 200 mg and acetaminphen 650 mg

Placebo

Placebo Comparator group

Description:

3 tablets of tableting compounds with no active ingredients

Treatment:

Drug: Placebo oral tablet