NCT03523988

Pre-emptive Analgesics in Orthodontic Treatment

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 12 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• NSAID
• Pain Management

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen gel capsule
DRUG	Ibuprofen	Ibuprofen gel capsule

Timeline

• Start date: 2017-05-02
• Primary completion: 2017-06-23
• Completion: 2017-08-01
• First posted: 2018-05-14
• Last updated: 2019-08-21
• Results posted: 2018-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study