Trial Outcomes & Findings for Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen (NCT NCT01334957)

NCT ID: NCT01334957

Last Updated: 2024-02-28

Results Overview

The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 300 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2024-02-28

Participant Flow

Adult hospitalized patients undergoing surgery

Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study. Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.

Participant milestones

Measure	Intravenous Ibuprofen Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Overall Study STARTED	300
Overall Study Received Single Dose	252
Overall Study Received Multiple Doses	48
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

Baseline characteristics by cohort

Measure	Intravenous Ibuprofen n=300 Participants Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Age, Customized Greater than or equal to 18 years of age	300 years n=5 Participants
Sex: Female, Male Female	189 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	271 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	60 Participants n=5 Participants
Race (NIH/OMB) White	229 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

Outcome measures

Measure	Intravenous Ibuprofen n=252 Participants Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.	8 Number of Serious Adverse Events

PRIMARY outcome

Timeframe: 6 hours

The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen

Outcome measures

Measure	Intravenous Ibuprofen n=252 Participants Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.	49 Number of Adverse Events

SECONDARY outcome

Timeframe: 6 hours

The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen

Outcome measures

Measure	Intravenous Ibuprofen n=48 Participants Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.	0 Number of Serious Adverse Events

SECONDARY outcome

Timeframe: 6 hours

The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen

Outcome measures

Measure	Intravenous Ibuprofen n=48 Participants Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.	16 Number of Adverse Events

SECONDARY outcome

Timeframe: 6 hours

Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.

Outcome measures

Measure	Intravenous Ibuprofen n=228 Participants Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.	30.9 units on a scale Interval 27.5 to 34.2

Adverse Events

Intravenous Ibuprofen

Serious events: 8 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous Ibuprofen n=300 participants at risk Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Gastrointestinal disorders Abdominal Compartment Syndrome	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Gastrointestinal disorders Peritoneal Adhesions	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Hepatobiliary disorders Bile Duct Stone	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Injury, poisoning and procedural complications Airway Complication Of Anaesthesia	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Investigations Oxygen Saturation Decreased	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Vascular disorders Hypertension	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Renal and urinary disorders Urinary Retention	0.33% 1/300 • Number of events 1 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen

Other adverse events

Measure	Intravenous Ibuprofen n=300 participants at risk Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
General disorders Infusion Site Pain	11.3% 34/300 • Number of events 34 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Gastrointestinal disorders Nausea	3.3% 10/300 • Number of events 10 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Gastrointestinal disorders Flatulence	3.0% 9/300 • Number of events 9 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Injury, poisoning and procedural complications Anaemia Postoperative	3.3% 10/300 • Number of events 10 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen
Cardiac disorders Bradycardia	2.7% 8/300 • Number of events 9 • During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen

Additional Information

Dr. Amy Rock

Cumberland Pharmaceuticals Inc.

Phone: 615-255-0068

Email: arock@cumberlandpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place