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Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

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ClinicalTrials.gov Identifier: NCT02268955
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Maricopa Integrated Health System

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.

Condition or disease Intervention/treatment Phase
Biliary Colic Drug: IV Ibuprofen Drug: Saline Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Actual Study Start Date : September 9, 2014
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 28, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268955


Locations
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United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
Sponsors and Collaborators
Maricopa Integrated Health System
Investigators
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Principal Investigator: Dan Quan, DO Maricopa Integrated Health System
  Study Documents (Full-Text)

Documents provided by Maricopa Integrated Health System:

Publications:

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Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT02268955     History of Changes
Other Study ID Numbers: 2014-067
First Posted: October 20, 2014    Key Record Dates
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019
Last Verified: March 2019
Keywords provided by Maricopa Integrated Health System:
Biliary Colic
Abdominal pain
Intravenous Ibuprofen
Additional relevant MeSH terms:
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Ibuprofen
Colic
Infant, Newborn, Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action