Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Study Overview
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Brief Summary
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Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is also known that ibuprofen levels in the blood rise higher and faster if the medication is taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also determine whether patients with sore throat prefer to take pill or liquid form of the medication.

Detailed Description
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Pain is a common emergency and urgent care complaint. Ibuprofen is known to be an effective treatment for many forms of pain. Sore throat has been established to be an acceptable model of analgesic effect, and ibuprofen has been found to offer relief in studies of sore throat. Several studies have demonstrated that ibuprofen in suspension is absorbed into the system more quickly and results in earlier maximum blood concentrations. To date, no study has evaluated onset to analgesia as reported by the patient for suspension versus tablet formation of ibuprofen in an emergency department population presenting with complaints of sore throat. This is a double blinded randomized placebo controlled trial to compare suspension versus tablet ibuprofen in an emergency department population presenting with sore throat. The purpose of this study is to assess whether ibuprofen in suspension form results in relief of pain more quickly than the tablet form of an equivalent dose of ibuprofen. We will also determine if there is an interval difference from time of analgesia administration to perception of analgesia that is clinically significant.

Official Title
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Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 12 years and less than 65 years Weight > 40 kg a provider order for ibuprofen to address pharyngitis pain. Initial Numeric Pain Score > 6 Exclusion Criteria: Known allergy or hypersensitivity to aspirin or NSAIDs Inability to swallow pills Inability to carry out informed consent in English Inability to complete a visual analog pain scale A concomitant order for another class of analgesic Use of analgesic within 8 hours Known 3rd trimester pregnancy Significant medical conditions where participation would pose an unnecessary barrier to ongoing care. Those taking opioid medications for more than 3 days Weight < 40 kg

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ibuprofen<br>liquid ibuprofen 400mg compared to tablet ibuprofen 400mg | Drug: Ibuprofen<br>* ibuprofen liquid 400mg vs. ibuprofen tablet 400mg<br>|
| Placebo Comparator: sugar pill or liquid<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of pain relief | Comparing liquid ibuprofen to tablet ibuprofen to determine which works faster to relieve sore throat pain. We will also determine whether patients with sore throat prefer to take pill or liquid form of medication. | 1 hour |