Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

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.

Study Overview

• Status: Unknown
• Conditions: Pharyngitis
• Intervention / Treatment: Drug: Ibuprofen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12204
      • Recruiting
      • Albany Medical Center Emergency Department
      • Principal Investigator: Wayne Triner, DO, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: Wayne R Triner, DO, MPH, Albany Medical College Department of Emergency Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: September 6, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 10, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 3003