Pre-emptive Analgesics in Orthodontic Treatment

NCT03523988 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00001679
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSAID; Pain Management

Keywords

Pre-emptive analgesics; Acetaminophen; Ibuprofen

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Ibuprofen

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Acetaminophen and Ibuprofen

EXPERIMENTAL

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

Drug: Acetaminophen; Drug: Ibuprofen

Interventions

Acetaminophen DRUG

Acetaminophen gel capsule

Also known as: Tylenol, Paracetamol

Acetaminophen; Acetaminophen and Ibuprofen

Ibuprofen DRUG

Ibuprofen gel capsule

Also known as: Advil

Acetaminophen and Ibuprofen; Ibuprofen

Eligibility Criteria

• Age: 12 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Orthodontic patient presenting for orthodontic treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

Low rate of participants returning results led to small number of participants analyzed.

Results Point of Contact

• Title: Lead Investigator
• Organization: University of Washington

akeith@uw.edu

4254668544

Study Officials

• Anne-Marie Bollen, DDS, MS, PhD

  University of Washington

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The medications were prepared by the Kelley-Ross Compounding Group (Seattle, WA) and were identical in appearance. The bottles were labeled as "A", "B", or "C" and the identity of the medications were not revealed until after the data analysis was completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients of the University of Washington Graduate Orthodontics Clinic

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 14, 2018
• Study Start: May 2, 2017
• Primary Completion: June 23, 2017
• Study Completion: August 1, 2017
• Last Updated: August 21, 2019
• Results First Posted: October 30, 2018

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)