Pre-emptive Analgesics in Orthodontic Treatment

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523988
• Other study ID #: STUDY00001679
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 1, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• NSAID
• Pain Management

Intervention

Drug:
• Acetaminophen
Acetaminophen gel capsule
• Ibuprofen
Ibuprofen gel capsule

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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