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Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Primary Purpose

Pharyngitis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albany Medical Center Emergency DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ibuprofen

sugar pill or liquid

Arm Description

liquid ibuprofen 400mg compared to tablet ibuprofen 400mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2012
Last Updated
March 10, 2014
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01681667
Brief Title
Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
Official Title
Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ibuprofen
Arm Type
Active Comparator
Arm Description
liquid ibuprofen 400mg compared to tablet ibuprofen 400mg
Arm Title
sugar pill or liquid
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
ibuprofen liquid 400mg vs. ibuprofen tablet 400mg
Primary Outcome Measure Information:
Title
Time of pain relief
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Robak, RN, MPH
Phone
518-262-3773
Email
RobakN@mail.amc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne R Triner, DO, MPH
Organizational Affiliation
Albany Medical College Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center Emergency Department
City
Albany
State/Province
New York
ZIP/Postal Code
12204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Triner, DO, MPH

12. IPD Sharing Statement

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Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

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