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Analgesic

Ibuprofen + Acetaminophen vs Ibuprofen for Orofacial Pain

Phase < 1

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently not taking antibiotics or analgesics

Healthy with no significant medical findings

Must not have

Stomach bleeding

Decisionally challenged individuals

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial will compare the effectiveness of ibuprofen and acetaminophen combined vs ibuprofen alone or placebo in controlling pain after orthodontic appliance placement.

Who is the study for?

This trial is for healthy individuals aged 12 and above who are about to start comprehensive orthodontic treatment, have not taken antibiotics or painkillers recently, and have no allergies to ibuprofen or acetaminophen. It excludes those under 12 or over 80, pregnant women, prisoners, people with decision-making impairments, kidney disease, liver issues, alcoholism, stomach ulcers or bleeding.

What is being tested?

The study aims to determine if a combination of ibuprofen (200 mg) and acetaminophen (650 mg) is more effective in managing pain after orthodontic appliance placement than just ibuprofen alone or a placebo. Participants will be randomly assigned to one of these three treatments for four days.

What are the potential side effects?

Possible side effects may include gastrointestinal issues like stomach upset or bleeding with ibuprofen use; liver damage from excessive acetaminophen intake; allergic reactions; fatigue; headache; dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently taking any antibiotics or painkillers.

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I am healthy with no major medical issues.

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I am at least 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bleeding in my stomach.

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I have difficulty making decisions due to a cognitive or mental health condition.

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I have stomach ulcers.

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I am currently taking blood thinners.

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I am either younger than 12 or older than 80.

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I have a history of kidney disease.

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I am allergic to one or more of the trial medications.

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I have liver damage or disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances. for reporting.