Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Biliary Colic Clinical Trial

Official title:

Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268955
• Other study ID #: 2014-067
• Status: Completed
• Phase: N/A
• Start date: September 9, 2014
• Est. completion date: June 28, 2017

Study information

• Verified date: March 2019
• Source: Maricopa Integrated Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 28, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Colic
• Colic

Intervention

Drug:
• IV Ibuprofen
Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
• Saline
Saline will be administered to the placebo group

Locations

Country	Name	City	State
United States	Maricopa Integrated Health System	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Maricopa Integrated Health System

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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