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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02268955
Other study ID # 2014-067
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2014
Est. completion date June 28, 2017

Study information

Verified date March 2019
Source Maricopa Integrated Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IV Ibuprofen
Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
Saline
Saline will be administered to the placebo group

Locations

Country Name City State
United States Maricopa Integrated Health System Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Maricopa Integrated Health System

Country where clinical trial is conducted

United States, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Pain Score 120 Minutes After Study Medication Administration Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable. 120 minutes post medication administration
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