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Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Primary Purpose

Biliary Colic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IV Ibuprofen
Saline
Sponsored by
Valleywise Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Colic focused on measuring Biliary Colic, Abdominal pain, Intravenous Ibuprofen

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maricopa Integrated Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group: Adults age 18-55 years

IV Ibuprofen: Adults age 18-55 years

Arm Description

Saline-only control group

Patients receiving intravenous ibuprofen therapy

Outcomes

Primary Outcome Measures

Pain Score 120 Minutes After Study Medication Administration
Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2014
Last Updated
April 25, 2019
Sponsor
Valleywise Health
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1. Study Identification

Unique Protocol Identification Number
NCT02268955
Brief Title
Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Official Title
Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2014 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
June 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valleywise Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Colic
Keywords
Biliary Colic, Abdominal pain, Intravenous Ibuprofen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group: Adults age 18-55 years
Arm Type
Placebo Comparator
Arm Description
Saline-only control group
Arm Title
IV Ibuprofen: Adults age 18-55 years
Arm Type
Active Comparator
Arm Description
Patients receiving intravenous ibuprofen therapy
Intervention Type
Drug
Intervention Name(s)
IV Ibuprofen
Other Intervention Name(s)
Caldolor, NeoProfen
Intervention Description
Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline will be administered to the placebo group
Primary Outcome Measure Information:
Title
Pain Score 120 Minutes After Study Medication Administration
Description
Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
Time Frame
120 minutes post medication administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Quan, DO
Organizational Affiliation
Valleywise Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21127424
Citation
Promes JT, Safcsak K, Pavliv L, Voss B, Rock A. A prospective, multicenter, randomized, double-blind trial of IV ibuprofen for treatment of fever and pain in burn patients. J Burn Care Res. 2011 Jan-Feb;32(1):79-90. doi: 10.1097/BCR.0b013e3182037300.
Results Reference
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PubMed Identifier
14622683
Citation
Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
Results Reference
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PubMed Identifier
20595477
Citation
Krudsood S, Tangpukdee N, Wilairatana P, Pothipak N, Duangdee C, Warrell DA, Looareesuwan S. Intravenous ibuprofen (IV-ibuprofen) controls fever effectively in adults with acute uncomplicated Plasmodium falciparum malaria but prolongs parasitemia. Am J Trop Med Hyg. 2010 Jul;83(1):51-5. doi: 10.4269/ajtmh.2010.09-0621.
Results Reference
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PubMed Identifier
20591173
Citation
Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.
Results Reference
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PubMed Identifier
20609131
Citation
Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.
Results Reference
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PubMed Identifier
20642488
Citation
Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
22316349
Citation
Smith HS, Voss B. Pharmacokinetics of intravenous ibuprofen: implications of time of infusion in the treatment of pain and fever. Drugs. 2012 Feb 12;72(3):327-37. doi: 10.2165/11599230-000000000-00000.
Results Reference
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PubMed Identifier
22540869
Citation
Colli A, Conte D, Valle SD, Sciola V, Fraquelli M. Meta-analysis: nonsteroidal anti-inflammatory drugs in biliary colic. Aliment Pharmacol Ther. 2012 Jun;35(12):1370-8. doi: 10.1111/j.1365-2036.2012.05115.x. Epub 2012 Apr 29.
Results Reference
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PubMed Identifier
12426013
Citation
Henderson SO, Swadron S, Newton E. Comparison of intravenous ketorolac and meperidine in the treatment of biliary colic. J Emerg Med. 2002 Oct;23(3):237-41. doi: 10.1016/s0736-4679(02)00524-3.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

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