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Completed

NCT Number: NCT02268955

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV ibuprofen

Drug

Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic

Other names: Caldolor, NeoProfen

Saline

Drug

Saline will be administered to the placebo group

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Valleywise Health

Other

Registry information

Official study title

Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2014
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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