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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 belowSelect...
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:Select...
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in visual analogue score (VAS) over time
Secondary study objectives
Dosing Compliance
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Ibuprofen and acetaminophenExperimental Treatment1 Intervention
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
Group II: IbuprofenActive Control1 Intervention
one 200 mg tablet of ibuprofen and 2 placebo tablets
Group III: PlaceboPlacebo Group1 Intervention
3 tablets of tableting compounds with no active ingredients
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,805 Previous Clinical Trials
2,821,971 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had bleeding in my stomach.I have difficulty making decisions due to a cognitive or mental health condition.I am not currently taking any antibiotics or painkillers.I have stomach ulcers.I had any necessary teeth extractions done at least 2 weeks before my braces were put on.I am currently taking blood thinners.I am either younger than 12 or older than 80.I am healthy with no major medical issues.I am scheduled for a major orthodontic treatment involving at least 10 teeth.I can safely take acetaminophen or ibuprofen.I have a history of kidney disease.You drink a lot of alcohol (3 or more drinks) during the study.I am at least 12 years old.I am allergic to one or more of the trial medications.I have liver damage or disease.I don't need antibiotics to prevent infection.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Ibuprofen
- Group 3: Ibuprofen and acetaminophen
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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