Pre-emptive Analgesics in Orthodontic Treatment

University of Washington

Status and phase: Completed; Phase 4

Conditions: NSAID; Pain Management

Treatments: Drug: Acetaminophen; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT03523988

STUDY00001679

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 12 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

73 participants in 3 patient groups

Acetaminophen

Active Comparator group

Description:

Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment

Treatment:

Drug: Acetaminophen

Ibuprofen

Active Comparator group

Description:

Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment

Treatment:

Drug: Ibuprofen

Acetaminophen and Ibuprofen

Experimental group

Description:

Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment

Treatment:

Drug: Ibuprofen

Drug: Acetaminophen