Trial Outcomes & Findings for Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic (NCT NCT02268955)
NCT ID: NCT02268955
Last Updated: 2019-05-14
Results Overview
Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
120 minutes post medication administration
Results posted on
2019-05-14
Participant Flow
Participant milestones
| Measure |
Control Group
Saline-only control group
Saline: Saline will be administered to the placebo group
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age for subjects analyzed.
Baseline characteristics by cohort
| Measure |
Control Group
n=11 Participants
Saline-only control group
Saline: Saline will be administered to the placebo group
|
IV Ibuprofen
n=11 Participants
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
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-55 years of age
|
9 Participants
n=9 Participants • Age for subjects analyzed.
|
9 Participants
n=9 Participants • Age for subjects analyzed.
|
18 Participants
n=18 Participants • Age for subjects analyzed.
|
|
Sex: Female, Male
Female
|
8 Participants
n=11 Participants • Male or Female for participants analyzed.
|
7 Participants
n=11 Participants • Male or Female for participants analyzed.
|
15 Participants
n=22 Participants • Male or Female for participants analyzed.
|
|
Sex: Female, Male
Male
|
3 Participants
n=11 Participants • Male or Female for participants analyzed.
|
4 Participants
n=11 Participants • Male or Female for participants analyzed.
|
7 Participants
n=22 Participants • Male or Female for participants analyzed.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Pain score
|
5 units on a scale
STANDARD_DEVIATION 0.015 • n=11 Participants
|
6 units on a scale
STANDARD_DEVIATION 0.029 • n=11 Participants
|
6 units on a scale
STANDARD_DEVIATION 0.001 • n=22 Participants
|
PRIMARY outcome
Timeframe: 120 minutes post medication administrationPain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
Outcome measures
| Measure |
Control Group: Adults Age 18-55 Years
n=9 Participants
Saline-only control group
Saline: Saline will be administered to the placebo group
|
IV Ibuprofen: Adults Age 18-55 Years
n=9 Participants
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
|
|---|---|---|
|
Pain Score 120 Minutes After Study Medication Administration
|
3.0 score on a scale
Interval 0.0 to 7.0
|
0.3 score on a scale
Interval 0.0 to 8.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Ibuprofen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place