Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

April 25, 2019 updated by: Valleywise Health

Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous ibuprofen will provide a clinically significant drop in self-reported patient pain level as measured by the visual analog scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is estimated over 20 million people aged 20-74 have gallbladder disease, with biliary colic being a common and painful symptom in these patients. Likely due to the relatively recent approval of intravenous ibuprofen use for fever and pain in adults, no assessment of its analgesic efficacy for biliary colic currently exists in the literature.

Utilizing a visual analog scale (VAS) for patient self-assessment of pain, this study will address this lack of evidence and identify intravenous ibuprofen's value as a novel analgesic in the treatment of biliary colic. Patients will be given a VAS at the time of study therapy administration, at 15-minute intervals during the first hour post-administration, and 30-minute intervals in the second hour. Though NSAID's have been extensively studied in the management of this phenomenon, this study aims to help optimize pain treatment of patients presenting to the Emergency Department with biliary colic, and potentially pave the way for future analgesic treatment comparison studies.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ages 18-55
  • Present to ED with right upper quadrant (RUQ) abdominal pain
  • Suspected diagnosis of biliary colic
  • Negative pregnancy test for women of childbearing potential (complete POC testing form)
  • No history of cholecystectomy

Exclusion Criteria:

  • Patient age < 18 or > 55
  • Incarcerated
  • Hemodynamic instability
  • Inability to reliably self-report or communicate pain intensity and pain relief
  • Taking Warfarin
  • Cannot consent of are not competent to consent
  • Hepatic, renal, cardiac failure
  • NSAID or morphine allergy
  • History congenital bleeding diathesis or platelet dysfunction
  • Peptic ulcer diseases
  • Are otherwise unsuitable for the study in the opinion of the investigator/sub-investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group: Adults age 18-55 years
Saline-only control group
Drug: Saline
Saline will be administered to the placebo group
Active Comparator: IV Ibuprofen: Adults age 18-55 years
Patients receiving intravenous ibuprofen therapy
Drug: IV Ibuprofen
Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
Other Names:
  • Caldolor
  • NeoProfen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score 120 Minutes After Study Medication Administration
Time Frame: 120 minutes post medication administration
Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
120 minutes post medication administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valleywise Health

Investigators

  • Principal Investigator: Dan Quan, DO, Valleywise Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2014

Primary Completion (Actual)

June 21, 2017

Study Completion (Actual)

June 28, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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