Clinical trial NCT02268955: Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Official title: Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Colic
Keywords: Biliary Colic
Abdominal pain
Intravenous Ibuprofen
Lead sponsor: Valleywise Health
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain Score 120 Minutes After Study Medication Administration
timeFrame: 120 minutes post medication administration
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
Study officials:
affiliation: Valleywise Health
name: Dan Quan, DO
role: PRINCIPAL_INVESTIGATOR
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