Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | September 2016 |
| Contact: | Dan Quan, DO |
| Email: | dan_quan@dmgaz.org |
| Phone: | 602-344-5058 |
Assessment of the 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.
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.
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.
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.
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
We found this trial at
1
site
2619 E. Pierce St.
Phoenix, Arizona 85008
Phoenix, Arizona 85008
602-344-5951
Principal Investigator: Dan Quan, DO
Phone: 602-344-5058
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