Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Albany Medical College
Sponsor:
Information provided by (Responsible Party):
Wayne Triner, Albany Medical College
ClinicalTrials.gov Identifier:
NCT01681667
First received: September 6, 2012
Last updated: March 10, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • 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 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681667

Contacts
Contact: Nancy Robak, RN, MPH 518-262-3773 RobakN@mail.amc.edu

Locations
United States, New York
Albany Medical Center Emergency Department Recruiting
Albany, New York, United States, 12204
Principal Investigator: Wayne Triner, DO, MPH         
Sponsors and Collaborators
Albany Medical College
Investigators
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: March 10, 2014
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 September 14, 2014