Pre-emptive Analgesics in Orthodontic Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; NSAID
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 59 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acetaminophen; Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment	Drug: Acetaminophen; Acetaminophen gel capsule; Other Names: Tylenol; Paracetamol
Active Comparator: Ibuprofen; Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment	Drug: Ibuprofen; Ibuprofen gel capsule; Other Names: Advil
Experimental: Acetaminophen and Ibuprofen; Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment	Drug: Acetaminophen; Acetaminophen gel capsule; Other Names: Tylenol; Paracetamol; Drug: Ibuprofen; Ibuprofen gel capsule; Other Names: Advil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Study Director: Anne-Marie Bollen, DDS, MS, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): June 23, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Ibuprofen; Acetaminophen; Pre-emptive analgesics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: STUDY00001679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No