Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Not Applicable

Completed

• Conditions: Biliary Colic
• Interventions: Drug: IV Ibuprofen; Drug: Saline

• Registration Number: NCT02268955
• Lead Sponsor: Valleywise Health

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 Timeline

• Study Start: 2014-09-09
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-20
• Primary Completion: 2017-06-21
• Study Completion: 2017-06-28
• Results First Submitted: 2018-01-29
• Status Verified: 2019-03
• Results First Submitted QC: 2019-04-25
• Last Update Submitted: 2019-04-25
• Results First Posted: 2019-05-14
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Ibuprofen: Adults age 18-55 years	IV Ibuprofen	Patients receiving intravenous ibuprofen therapy
Control Group: Adults age 18-55 years	Saline	Saline-only control group

Primary Outcome Measures

Name	Time	Method
Pain Score 120 Minutes After Study Medication Administration	120 minutes post medication administration	Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.

Trial Locations

Locations (1)

Maricopa Integrated Health System; 🇺🇸 Phoenix, Arizona, United States