NCT03523988 - Pre-emptive Analgesics in Orthodontic Treatment | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

73

Conditions

NSAID Pain Management

Interventions

AcetaminophenDRUG

Acetaminophen gel capsule

IbuprofenDRUG

Ibuprofen gel capsule

Eligibility

Sex: ALLMin age: 12 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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."

Time frame: 6 hours after orthodontic treatment

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."

Time frame: 1 day after orthodontic treatment

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."

Time frame: 2 days after orthodontic treatment