Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

• Sponsor: Valleywise Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02268955
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Colic	Drug: IV Ibuprofen; Drug: Saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
• Actual Study Start Date: Sep 9, 2014
• Actual Primary Completion Date: Jun 21, 2017
• Actual Study Completion Date: Jun 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain Score 120 Minutes After Study Medication Administration [120 minutes post medication administration]

   Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Integrated Health System	Phoenix	Arizona	United States	85008

Sponsors and Collaborators

• Valleywise Health

Investigators

• Principal Investigator: Dan Quan, DO, Valleywise Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 5, 2014

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Valleywise Health
• ClinicalTrials.gov Identifier: NCT02268955
• Other Study ID Numbers: 2014-067
• First Posted: Oct 20, 2014
• Last Update Posted: May 14, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Valleywise Health: Biliary Colic; Abdominal pain; Intravenous Ibuprofen
• Additional relevant MeSH terms: Colic; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Control Group	IV Ibuprofen
Arm/Group Description	Saline-only control group Saline: Saline will be administered to the placebo group	Patients receiving intravenous ibuprofen therapy IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
Period Title: Overall Study
STARTED	11	11
COMPLETED	9	9
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Control Group	IV Ibuprofen	Total
Arm/Group Description	Saline-only control group Saline: Saline will be administered to the placebo group	Patients receiving intravenous ibuprofen therapy IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic	Total of all reporting groups
Overall Participants	11	11	22
Age, Customized (Count of Participants)
18-55 years of age	9 81.8%	9 81.8%	18 81.8%
Sex: Female, Male (Count of Participants)
Female	8 72.7%	7 63.6%	15 68.2%
Male	3 27.3%	4 36.4%	7 31.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Pain score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5 (0.015)	6 (0.029)	6 (0.001)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group: Adults Age 18-55 Years	IV Ibuprofen: Adults Age 18-55 Years
Arm/Group Description	Saline-only control group Saline: Saline will be administered to the placebo group	Patients receiving intravenous ibuprofen therapy IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
Measure Participants	9	9
Median (Full Range) [score on a scale]	3.0	0.3

Adverse Events

Time Frame	During study treatment (about 2 hours).
Arm/Group Title	Control Group		IV Ibuprofen
Arm/Group Description	Saline-only control group Saline: Saline will be administered to the placebo group		Patients receiving intravenous ibuprofen therapy IV Ibuprofen: Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
All Cause Mortality
	Control Group		IV Ibuprofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)
Serious Adverse Events
	Control Group		IV Ibuprofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		IV Ibuprofen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)

Limitations/Caveats

There were not enough patients enrolled.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.