NCT02268955

Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Valleywise Health · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Colic

Interventions

Type	Name	Description
DRUG	IV Ibuprofen	Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
DRUG	Saline	Saline will be administered to the placebo group

Timeline

• Start date: 2014-09-09
• Primary completion: 2017-06-21
• Completion: 2017-06-28
• First posted: 2014-10-20
• Last updated: 2019-05-14
• Results posted: 2019-05-14

Locations

1 site across 1 country: United States