Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

This study is currently recruiting participants.
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

September 6, 2012
March 10, 2014
September 2013
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01681667 on ClinicalTrials.gov Archive Site
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Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Pharyngitis
Drug: Ibuprofen
ibuprofen liquid 400mg vs. ibuprofen tablet 400mg
  • Active Comparator: ibuprofen
    liquid ibuprofen 400mg compared to tablet ibuprofen 400mg
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: sugar pill or liquid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
12 Years to 65 Years
No
Contact: Nancy Robak, RN, MPH 518-262-3773 RobakN@mail.amc.edu
United States
 
NCT01681667
3003
Yes
Wayne Triner, Albany Medical College
Albany Medical College
Not Provided
Principal Investigator: Wayne R Triner, DO, MPH Albany Medical College Department of Emergency Medicine
Albany Medical College
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP