Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Adults age 18-55 years | Placebo Comparator | Saline-only control group |
|
| IV Ibuprofen: Adults age 18-55 years | Active Comparator | Patients receiving intravenous ibuprofen therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Ibuprofen | Drug | Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dan Quan, DO | Valleywise Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Integrated Health System | Phoenix | Arizona | 85008 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21127424 | Background | 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. | |
| 14622683 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Saline-only control group Saline: Saline will be administered to the placebo group |
| FG001 | IV Ibuprofen | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data for the population is VAS pain score prior to Intravenous Ibuprofen or Placebo administration.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Saline-only control group Saline: Saline will be administered to the placebo group |
| BG001 | IV Ibuprofen | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Ages 18-55 were enrolled. Individual subject's age data was not reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | score on a scale | 120 minutes post medication administration |
|
During study treatment (about 2 hours).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Saline-only control group Saline: Saline will be administered to the placebo group |
Not provided
Not provided
There were not enough patients enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Quan, DO | Maricopa Integrated Health System | 602-344-5058 | dany_quan@dmgaz.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2014 | Dec 12, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Saline | Drug | Saline will be administered to the placebo group |
|
| 20595477 | 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. |
| 20591173 | 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. |
| 20609131 | 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. |
| 20642488 | 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. |
| 19843482 | 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. |
| 22316349 | 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. |
| 22540869 | 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. |
| 12426013 | 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. |
| 18637080 | 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. |
| BG002 | Total | Total of all reporting groups |
Age for subjects analyzed.
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Male or Female for participants analyzed. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pain score | Visual Analog pain score where 0=no pain, and 10=worse pain imaginable. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | IV Ibuprofen | 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 | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided
| D012817 | Signs and Symptoms, Digestive |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |