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Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Information source: Maricopa Integrated Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Biliary Colic

Intervention: IV Ibuprofen (Drug); Saline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Maricopa Integrated Health System

Official(s) and/or principal investigator(s):
Dan Quan, DO, Principal Investigator, Affiliation: Maricopa Integrated Health System

Overall contact:
Dan Quan, DO, Phone: 602-344-5058, Email: dan_quan@dmgaz.org

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.

Clinical Details

Official title: Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain Level - VAS

Secondary outcome:

Change from pain level (VAS) at 15 minutes post-administration

Change from pain level (VAS) at 30 minutes post-administration

Change from pain level (VAS) at 45 minutes post-administration

Change from pain level (VAS) at 60 minutes post-administration

Change from pain level (VAS) at 90 minutes post-administration

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Dan Quan, DO, Phone: 602-344-5058, Email: dan_quan@dmgaz.org

Maricopa Integrated Health System, Phoenix, Arizona 85008, United States; Recruiting
Dan Quan, DO, Phone: 602-344-5058, Email: dan_quan@dmgaz.org
Mary Mulrow, RN, MN, Phone: 602-344-5058, Email: mary.mulrow@mihs.org
Dan Quan, DO, Principal Investigator
Frank LoVecchio, DO, MPH, Sub-Investigator
Additional Information

Related publications:

Promes JT, Safcsak K, Pavliv L, Voss B, Rock A. A prospective, multicenter, randomized, double-blind trial of IV ibuprofen for treatment of fever and pain in burn patients. J Burn Care Res. 2011 Jan-Feb;32(1):79-90. doi: 10.1097/BCR.0b013e3182037300.

Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14.

Krudsood S, Tangpukdee N, Wilairatana P, Pothipak N, Duangdee C, Warrell DA, Looareesuwan S. Intravenous ibuprofen (IV-ibuprofen) controls fever effectively in adults with acute uncomplicated Plasmodium falciparum malaria but prolongs parasitemia. Am J Trop Med Hyg. 2010 Jul;83(1):51-5. doi: 10.4269/ajtmh.2010.09-0621.

Morris PE, Promes JT, Guntupalli KK, Wright PE, Arons MM. A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.

Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.

Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.

Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.

Smith HS, Voss B. Pharmacokinetics of intravenous ibuprofen: implications of time of infusion in the treatment of pain and fever. Drugs. 2012 Feb 12;72(3):327-37. doi: 10.2165/11599230-000000000-00000. Review.

Colli A, Conte D, Valle SD, Sciola V, Fraquelli M. Meta-analysis: nonsteroidal anti-inflammatory drugs in biliary colic. Aliment Pharmacol Ther. 2012 Jun;35(12):1370-8. doi: 10.1111/j.1365-2036.2012.05115.x. Epub 2012 Apr 29.

Henderson SO, Swadron S, Newton E. Comparison of intravenous ketorolac and meperidine in the treatment of biliary colic. J Emerg Med. 2002 Oct;23(3):237-41.

Olsen JC, McGrath NA, Schwarz DG, Cutcliffe BJ, Stern JL. A double-blind randomized clinical trial evaluating the analgesic efficacy of ketorolac versus butorphanol for patients with suspected biliary colic in the emergency department. Acad Emerg Med. 2008 Aug;15(8):718-22. doi: 10.1111/j.1553-2712.2008.00178.x. Epub 2008 Jul 11.

Starting date: September 2014
Last updated: May 24, 2015

Page last updated: August 23, 2015

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