Trial · NCT01334944

Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

NCT01334944, Phase 4, Completed, Cumberland Pharmaceuticals; results first posted 2014-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen. Trials, record NCT01334944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01334944

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
NCT number: NCT01334944
Status: Completed
Phases: Phase 4
Enrollment: 150 participants, actual
Lead sponsor: Cumberland Pharmaceuticals
Conditions: Pain, Fever
Interventions: Intravenous ibuprofen
First posted: 2011-04-13
Last updated: 2023-07-05
Results first posted: 2014-06-23

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	6 hours	The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	6 hours	The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).
Primary	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour	The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).
Secondary	To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever	4 hours	The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration
Secondary	To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).	4 hours	The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. 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.
Secondary	To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain	24 hours	The incidence of treatment-emergent serious adverse events occurring through extended dosing.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	6 hours		Number of Serious Adverse Events	NUMBER
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	6 hours	This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen	Number of Events	NUMBER
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting	1 hour		Degree Fahrenheit	MEAN
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour		Beats Per Minute	MEAN
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour		Breaths Per Minute	MEAN
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour		mm Hg	MEAN
PRIMARY	To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	1 hour		mm Hg	MEAN
SECONDARY	To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever	4 hours		Degree Fahrenheit	MEAN
SECONDARY	To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).	4 hours		units on a scale	MEAN
SECONDARY	To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain	24 hours		Number of Serious Adverse Events	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Fever	0		Number of Serious Adverse Events
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Pain	0		Number of Serious Adverse Events
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Fever	0		Number of Events
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Pain	16		Number of Events
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting	Fever	-0.9	95% Confidence Interval -2.7 to 0.3	Degree Fahrenheit
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting	Pain	-0.1	95% Confidence Interval -3.2 to 1.6	Degree Fahrenheit
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Fever	-2	95% Confidence Interval -16 to 8	Beats Per Minute
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Pain	-1	95% Confidence Interval -34 to 62	Beats Per Minute
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Fever	-1	95% Confidence Interval -5 to 2	Breaths Per Minute
To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.	Pain	0	95% Confidence Interval -17 to 14	Breaths Per Minute

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fever	11
Overall Study	STARTED	Pain	139
Overall Study	Received Singel Dose	Fever	1
Overall Study	Received Singel Dose	Pain	96
Overall Study	Received Multiple Doses	Fever	10
Overall Study	Received Multiple Doses	Pain	43
Overall Study	COMPLETED	Fever	11
Overall Study	COMPLETED	Pain	139
Overall Study	NOT COMPLETED	Fever	0
Overall Study	NOT COMPLETED	Pain	0

Source ClinicalTrials.gov

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Infusion Site Pain	Injury, poisoning and procedural complications	Fever	0	11	0
other	Infusion Site Pain	Injury, poisoning and procedural complications	Pain	22	139	24
other	Infusion Site Warmth	Injury, poisoning and procedural complications	Fever	0	11	0
other	Infusion Site Warmth	Injury, poisoning and procedural complications	Pain	1	139	1
other	Injection Site Pain	Injury, poisoning and procedural complications	Fever	0	11	0
other	Injection Site Pain	Injury, poisoning and procedural complications	Pain	1	139	1
other	Flatulence	Gastrointestinal disorders	Fever	0	11	0
other	Flatulence	Gastrointestinal disorders	Pain	8	139	8
other	Nausea	Gastrointestinal disorders	Fever	0	11	0
other	Nausea	Gastrointestinal disorders	Pain	5	139	6

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fever
Total, all-cause mortality	Pain
Total, other adverse events	Fever	0	11
Total, other adverse events	Pain	43	139
Total, serious adverse events	Fever	0	11
Total, serious adverse events	Pain	1	139

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Fever vs Pain: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01334944

GET https://conductscience.org/api/trials/v1/NCT01334944/events?page=2

API reference For AI assistants