Biliary Colic
Conditions
Keywords
Biliary Colic, Abdominal pain, Intravenous Ibuprofen
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.
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.
Interventions
DRUGIV Ibuprofen
Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
DRUGSaline
Saline will be administered to the placebo group
Sponsors
Valleywise Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Saline-only control group
Saline: Saline will be administered to the placebo group | 11 |
| 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 | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Control Group | IV Ibuprofen | Total |
|---|---|---|---|
| Age, Customized 18-55 years of age | 9 Participants | 9 Participants | 18 Participants |
| Pain score | 5 units on a scale STANDARD_DEVIATION 0.015 | 6 units on a scale STANDARD_DEVIATION 0.029 | 6 units on a scale STANDARD_DEVIATION 0.001 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
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.
Time frame: 120 minutes post medication administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group: Adults Age 18-55 Years | Pain Score 120 Minutes After Study Medication Administration | 3.0 score on a scale |
| IV Ibuprofen: Adults Age 18-55 Years | Pain Score 120 Minutes After Study Medication Administration | 0.3 score on a scale |