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Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Valleywise Health

Tracking Information
First Submitted Date  ICMJE October 16, 2014
First Posted Date  ICMJE October 20, 2014
Results First Submitted Date  ICMJE January 29, 2018
Results First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE September 9, 2014
Actual Primary Completion Date June 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Pain Level - VAS [ Time Frame: 15 minutes post-administration ]
Pain levels measured through Visual Analog Scale (VAS)
Change History Complete list of historical versions of study NCT02268955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
  • Change from pain level (VAS) at 15 minutes post-administration [ Time Frame: 30 minutes post-administration ]
    Pain levels measured through Visual Analog Scale (VAS)
  • Change from pain level (VAS) at 30 minutes post-administration [ Time Frame: 45 minutes post-administration ]
  • Change from pain level (VAS) at 45 minutes post-administration [ Time Frame: 60 minutes post-administration ]
  • Change from pain level (VAS) at 60 minutes post-administration [ Time Frame: 90 minutes post-administration ]
  • Change from pain level (VAS) at 90 minutes post-administration [ Time Frame: 120 minutes post-administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Official Title  ICMJE Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Biliary Colic
Intervention  ICMJE
  • 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
  • Drug: Saline
    Saline will be administered to the placebo group
Study Arms  ICMJE
  • Placebo Comparator: Control Group: Adults age 18-55 years
    Saline-only control group
    Intervention: Drug: Saline
  • Active Comparator: IV Ibuprofen: Adults age 18-55 years
    Patients receiving intravenous ibuprofen therapy
    Intervention: Drug: IV Ibuprofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2014)
36
Actual Study Completion Date  ICMJE June 28, 2017
Actual Primary Completion Date June 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02268955
Other Study ID Numbers  ICMJE 2014-067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valleywise Health
Study Sponsor  ICMJE Valleywise Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Quan, DO Valleywise Health
PRS Account Valleywise Health
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP