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

Conditions

• Pain, Orofacial

Eligibility Criteria

Sex

ALL

Age

12 Years - 80 Years

Healthy Volunteers

Accepted

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 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.
• 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.

Study Details

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.

Key Dates

Start date

Dec 10, 2019

Status verified

May 2026

Primary completion

Jun 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

375 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Ibuprofen
  one 200 mg tablet of ibuprofen and 2 placebo tablets
• Experimental: Ibuprofen and acetaminophen
  one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
• Placebo Comparator: Placebo
  3 tablets of tableting compounds with no active ingredients

Primary Outcome Measure

Change in visual analogue score (VAS) over time [ Time Frame: 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances ]

Central Contacts

• Clifton M Carey, PhD
  3037241046
  [email protected]

Locations (1)

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