Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Pharyngitis Clinical Trial

Official title:

Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01681667
• Other study ID #: 3003
• Status: Recruiting
• Phase: Phase 4
• First received: September 6, 2012
• Last updated: March 10, 2014
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2014
• Source: Albany Medical College
• Contact: Nancy Robak, RN, MPH
• Phone: 518-262-3773
• Email: RobakN[@]mail.amc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Drug:
• Ibuprofen
ibuprofen liquid 400mg vs. ibuprofen tablet 400mg

Locations

Country	Name	City	State
United States	Albany Medical Center Emergency Department	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No