Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pharyngitis |
Drug: Ibuprofen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain |
- Time of pain relief [ Time Frame: 1 hour ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ibuprofen
liquid ibuprofen 400mg compared to tablet ibuprofen 400mg
|
Drug: Ibuprofen
ibuprofen liquid 400mg vs. ibuprofen tablet 400mg
|
| Placebo Comparator: sugar pill or liquid |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than 12 years and less than 65 years
- Weight > 60 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 < 60 kg
Contacts and Locations| Contact: Nancy Robak, RN, MPH | 518-262-3773 | RobakN@mail.amc.edu |
| United States, New York | |
| Albany Medical Center Emergency Department | Not yet recruiting |
| Albany, New York, United States, 12204 | |
| Principal Investigator: Wayne Triner, DO, MPH | |
| Principal Investigator: | Wayne R Triner, DO, MPH | Albany Medical College Department of Emergency Medicine |
More Information
No publications provided
| Responsible Party: | Wayne Triner, Professor and Research Director Dept.of Emergency Medicine, Albany Medical College |
| ClinicalTrials.gov Identifier: | NCT01681667 History of Changes |
| Other Study ID Numbers: | 3003 |
| Study First Received: | September 6, 2012 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013