Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

NCT04059172 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 17-1449
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.

Conditions

Pain, Orofacial

Outcome Measures

Primary Outcomes (1)

• Change in visual analogue score (VAS) over time

  Primary outcomes with be the pain values recorded by subjects when chewing on the 100-mm VAS at set times.The VAS line for each time period will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right.

  0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances

Secondary Outcomes (1)

• Dosing Compliance

  to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances.

Study Arms (3)

Ibuprofen

ACTIVE COMPARATOR

one 200 mg tablet of ibuprofen and 2 placebo tablets

Drug: Ibuprofen 200 mg

Ibuprofen and acetaminophen

EXPERIMENTAL

one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen

Drug: Ibuprofen 200 mg and acetaminphen 650 mg

Placebo

PLACEBO COMPARATOR

3 tablets of tableting compounds with no active ingredients

Drug: Placebo oral tablet

Interventions

Ibuprofen 200 mg and acetaminphen 650 mg DRUG

For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.

Ibuprofen and acetaminophen

Ibuprofen 200 mg DRUG

For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.

Ibuprofen

Placebo oral tablet DRUG

For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively. For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.

Placebo

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
• extractions, if required, performed at least 2 weeks before appliance and archwire placement;
• healthy with no significant medical findings;
• no prophylactic antibiotic coverage required;
• currently not taking antibiotics or analgesics;
• no contraindications to the use of acetaminophen or ibuprofen; and
• minimum age of 12 years

You may not qualify if:

• Under the age of 12 or over the age of 80,
• prisoners,
• pregnant women,
• decisionally challenged individuals,
• allergy to either medication,
• history of kidney disease,
• liver damage or disease,
• alcoholism/use of 3 or more alcoholic drinks during study period,
• use of blood thinners,
• stomach ulcers or
• stomach bleeding.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, School of Dental Medicine

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Facial Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Clifton M Carey, PhD

CONTACT

3037241046; clifton.carey@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Ibuprofen, acetaminophen and placebo tablets have been prepared to look identical by a pharmacy. The appropriate tablets are placed in a blister pack to be delivered to the study participant. The number of tablets are the same for each blister in all blister packs. The study participant, care provider, investigators and the outcomes assessor are all blinded to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two investigational groups and a placebo group

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 16, 2019
• Study Start: December 10, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)