Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
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|ClinicalTrials.gov Identifier: NCT02268955|
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Biliary Colic||Drug: IV Ibuprofen Drug: Saline||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic|
|Actual Study Start Date :||September 9, 2014|
|Actual Primary Completion Date :||June 21, 2017|
|Actual Study Completion Date :||June 28, 2017|
Placebo Comparator: Control Group: Adults age 18-55 years
Saline-only control group
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
- Pain Score 120 Minutes After Study Medication Administration [ Time Frame: 120 minutes post medication administration ]Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268955
|United States, Arizona|
|Maricopa Integrated Health System|
|Phoenix, Arizona, United States, 85008|
|Principal Investigator:||Dan Quan, DO||Maricopa Integrated Health System|