Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

NCT02268955 | Completed Results

• 1 other identifier: 2014-067
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Colic

Keywords

Biliary Colic; Abdominal pain; Intravenous Ibuprofen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group: Adults age 18-55 years

PLACEBO COMPARATOR

Saline-only control group

Drug: Saline

IV Ibuprofen: Adults age 18-55 years

ACTIVE COMPARATOR

Patients receiving intravenous ibuprofen therapy

Drug: IV Ibuprofen

Interventions

IV Ibuprofen DRUG

Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic

Also known as: Caldolor, NeoProfen

IV Ibuprofen: Adults age 18-55 years

Saline DRUG

Saline will be administered to the placebo group

Control Group: Adults age 18-55 years

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valleywise Health: lead

Study Sites (1)

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Location

Related Publications (11)

• 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.

  PMID: 21127424 BACKGROUND

• 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. doi: 10.1016/s1526-5900(03)00716-8.

  PMID: 14622683 BACKGROUND

• 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.

  PMID: 20595477 BACKGROUND

• 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.

  PMID: 20591173 BACKGROUND

• 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.

  PMID: 20609131 BACKGROUND

• 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.

  PMID: 20642488 BACKGROUND

• 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.

  PMID: 19843482 BACKGROUND

• 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.

  PMID: 22316349 BACKGROUND

• 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.

  PMID: 22540869 BACKGROUND

• 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. doi: 10.1016/s0736-4679(02)00524-3.

  PMID: 12426013 BACKGROUND

• 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.

  PMID: 18637080 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Interventions

Ibuprofen; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

There were not enough patients enrolled.

Results Point of Contact

• Title: Dan Quan, DO
• Organization: Maricopa Integrated Health System

dany_quan@dmgaz.org

602-344-5058

Study Officials

• Dan Quan, DO

  Valleywise Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: September 9, 2014
• Primary Completion: June 21, 2017
• Study Completion: June 28, 2017
• Last Updated: May 14, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-03

Locations

US (1)