Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-05-31

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.

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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.

Conditions

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Pharyngitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ibuprofen

liquid ibuprofen 400mg compared to tablet ibuprofen 400mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

ibuprofen liquid 400mg vs. ibuprofen tablet 400mg

sugar pill or liquid

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Ibuprofen

ibuprofen liquid 400mg vs. ibuprofen tablet 400mg

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No