Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Conditions
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Biliary Colic

Intervention / Treatment
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* Drug: IV Ibuprofen
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group: Adults age 18-55 years<br>Saline-only control group | Drug: Saline<br>* Saline will be administered to the placebo group<br>|
| Active Comparator: IV Ibuprofen: Adults age 18-55 years<br>Patients receiving intravenous ibuprofen therapy | Drug: IV Ibuprofen<br>* Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic<br>* Other names: NeoProfen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score 120 Minutes After Study Medication Administration | Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable. | 120 minutes post medication administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary Colic, Abdominal pain, Intravenous Ibuprofen