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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
Sponsor:
Information provided by (Responsible Party):
Maricopa Integrated Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Biliary Colic
Interventions Drug: IV Ibuprofen
Drug: Saline
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group IV Ibuprofen
Hide 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
Arm/Group Title Control Group IV Ibuprofen Total
Hide 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 Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
Baseline data for the population is VAS pain score prior to Intravenous Ibuprofen or Placebo administration.
Age, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
18-55 years of age Number Analyzed 9 participants 9 participants 18 participants
9
 100.0%
9
 100.0%
18
 100.0%
[1]
Measure Description: Ages 18-55 were enrolled. Individual subject's age data was not reported.
[2]
Measure Analysis Population Description: Age for subjects analyzed.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
8
  72.7%
7
  63.6%
15
  68.2%
Male
3
  27.3%
4
  36.4%
7
  31.8%
[1]
Measure Analysis Population Description: Male or Female for participants analyzed.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Pain score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 11 participants 22 participants
5  (0.015) 6  (0.029) 6  (0.001)
[1]
Measure Description: Visual Analog pain score where 0=no pain, and 10=worse pain imaginable.
1.Primary Outcome
Title Pain Score 120 Minutes After Study Medication Administration
Hide Description Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
Time Frame 120 minutes post medication administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group: Adults Age 18-55 Years IV Ibuprofen: Adults Age 18-55 Years
Hide 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

Overall Number of Participants Analyzed 9 9
Median (Full Range)
Unit of Measure: score on a scale
3.0
(0.0 to 7.0)
0.3
(0.0 to 8.0)
Time Frame During study treatment (about 2 hours).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group IV Ibuprofen
Hide 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 (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group IV Ibuprofen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group IV Ibuprofen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dan Quan, DO
Organization: Maricopa Integrated Health System
Phone: 602-344-5058
EMail: dany_quan@dmgaz.org
Publications:
Layout table for additonal information
Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT02268955     History of Changes
Other Study ID Numbers: 2014-067
First Submitted: October 16, 2014
First Posted: October 20, 2014
Results First Submitted: January 29, 2018
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019