Trial · NCT01002573

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

NCT01002573, Phase 3, Completed, Cumberland Pharmaceuticals; results first posted 2016-11-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients. Trials, record NCT01002573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01002573

On this page

Trial

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

Title: Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
NCT number: NCT01002573
Status: Completed
Phases: Phase 3
Enrollment: 118 participants, actual
Lead sponsor: Cumberland Pharmaceuticals
Conditions: Fever
Interventions: ibuprofen, acetaminophen
First posted: 2009-10-27
Last updated: 2016-11-07
Results first posted: 2016-11-07

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Fever Reduction	0 to 2 hours post-dose	Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
Secondary	Change From Baseline in Temperature After the First 30 Minutes of Treatment	30 minutes following treatment	Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.
Secondary	Change From Baseline in Temperature After the First 60 Minutes of Treatment	60 minutes following treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.
Secondary	Change in Temperature	4 hours following treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.
Secondary	Change From Baseline in Temperature After the First Four Hours of Treatment	0 to 4 hours post-dose	Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)
Secondary	Time to Afebrility (in Hours)	4 Hour post treatment	Tme to afebrility (temperature less than 100.4 ºF \[38 ºC\]) in patients receiving intravenous ibuprofen and APAP.
Secondary	Number of Afebrile and Febrile Subject at 4 Hours Post-Dose	4 Hours Post-Dose	Number of Afebrile and Febrile Subject at 4 Hours Following Treatment

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Fever Reduction	0 to 2 hours post-dose	Some participants data was not included in the analysis due to having too few/insufficient data	degree Celsius*Time	MEAN
SECONDARY	Change From Baseline in Temperature After the First 30 Minutes of Treatment	30 minutes following treatment	Some participants data was not included in the analysis due to having too few/insufficient data	Celsius	MEAN
SECONDARY	Change From Baseline in Temperature After the First 60 Minutes of Treatment	60 minutes following treatment	Some participants data was not included in the analysis due to having too few/insufficient data	Celsius	MEAN
SECONDARY	Change in Temperature	4 hours following treatment	Some participants data was not included in the analysis due to having too few/insufficient data	Celsius	MEAN
SECONDARY	Change From Baseline in Temperature After the First Four Hours of Treatment	0 to 4 hours post-dose	Some participants data was not included in the analysis due to having too few/insufficient data	degree Celsius*Time	MEAN
SECONDARY	Time to Afebrility (in Hours)	4 Hour post treatment		Hours	MEAN
SECONDARY	Number of Afebrile and Febrile Subject at 4 Hours Post-Dose	4 Hours Post-Dose	Some participants data was not included in the analysis due to having too few/insufficient data	participants	NUMBER

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Fever Reduction	Ibuprofen	-1.5	Standard Deviation 1.11	degree Celsius*Time
Fever Reduction	Acetaminophen	-0.9	Standard Deviation 0.89	degree Celsius*Time
Change From Baseline in Temperature After the First 30 Minutes of Treatment	Ibuprofen	-0.5	Standard Deviation 0.50	Celsius
Change From Baseline in Temperature After the First 30 Minutes of Treatment	Acetaminophen	-0.3	Standard Deviation 0.49	Celsius
Change From Baseline in Temperature After the First 60 Minutes of Treatment	Ibuprofen	-0.9	Standard Deviation 0.69	Celsius
Change From Baseline in Temperature After the First 60 Minutes of Treatment	Acetaminophen	-0.5	Standard Deviation 0.50	Celsius
Change in Temperature	Ibuprofen	-1.5	Standard Deviation 0.92	Celsius
Change in Temperature	Acetaminophen	-0.9	Standard Deviation 0.92	Celsius
Change From Baseline in Temperature After the First Four Hours of Treatment	Ibuprofen	-4.4	Standard Deviation 2.59	degree Celsius*Time
Change From Baseline in Temperature After the First Four Hours of Treatment	Acetaminophen	-2.6	Standard Deviation 2.02	degree Celsius*Time

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ibuprofen	58
Overall Study	STARTED	Acetaminophen	60
Overall Study	COMPLETED	Ibuprofen	47
Overall Study	COMPLETED	Acetaminophen	53
Overall Study	NOT COMPLETED	Ibuprofen	11
Overall Study	NOT COMPLETED	Acetaminophen	7

Source ClinicalTrials.gov

Adverse events40

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	Vomiting	Gastrointestinal disorders	Ibuprofen	3	47	4
other	Vomiting	Gastrointestinal disorders	Acetaminophen	3	53	3
other	Diarrhoea	Gastrointestinal disorders	Ibuprofen	1	47	1
other	Diarrhoea	Gastrointestinal disorders	Acetaminophen	4	53	4
other	Nausea	Gastrointestinal disorders	Ibuprofen	3	47	3
other	Nausea	Gastrointestinal disorders	Acetaminophen	2	53	2
other	Aspartate Aminotransferase Increased	Investigations	Ibuprofen	2	47	2
other	Aspartate Aminotransferase Increased	Investigations	Acetaminophen	2	53	2
other	Blood Lactate Dehydrogenase Increased	Investigations	Ibuprofen	1	47	1
other	Blood Lactate Dehydrogenase Increased	Investigations	Acetaminophen	3	53	3

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ibuprofen
Total, all-cause mortality	Acetaminophen
Total, other adverse events	Ibuprofen	28	47
Total, other adverse events	Acetaminophen	22	53
Total, serious adverse events	Ibuprofen	2	47
Total, serious adverse events	Acetaminophen	2	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28143430	DERIVED

Source PubMed

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
Ibuprofen vs Acetaminophen: 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/NCT01002573

GET https://conductscience.org/api/trials/v1/NCT01002573/events?page=2

API reference For AI assistants