Skip to main content
OpenTrials
Completed

NCT Number: NCT01002573

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

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maricopa Medical Center, Phoenix, Arizona, United States

Loading trial locations.

About this study

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
  • Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
  • Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).

Exclusion criteria

  • Have inadequate intravenous access.
  • Have received antipyretic drug therapy within 2 hours before dosing.
  • Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
  • Have received another investigational drug within the past 30 days.
  • Be otherwise unsuitable for the study, in the opinion of the Investigator.
  • Have a fever due to hyperthermia.
  • Pregnant or nursing.

Treatment and study plan

Ibuprofen

Drug

Ibuprofen, 10 mg/kg

Acetaminophen

Drug

Acetaminophen, 10mg/kg

Other names: APAP (acetaminophen), paracetamol

Primary outcomes

  1. Fever Reduction

    Time frame: 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 outcomes

  1. Change From Baseline in Temperature After the First 30 Minutes of Treatment

    Time frame: 30 minutes following treatment

    Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.

  2. Change From Baseline in Temperature After the First 60 Minutes of Treatment

    Time frame: 60 minutes following treatment

    Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.

  3. Change in Temperature

    Time frame: 4 hours following treatment

    Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.

  4. Change From Baseline in Temperature After the First Four Hours of Treatment

    Time frame: 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)

  5. Time to Afebrility (in Hours)

    Time frame: 4 Hour post treatment

    Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.

  6. Number of Afebrile and Febrile Subject at 4 Hours Post-Dose

    Time frame: 4 Hours Post-Dose

    Number of Afebrile and Febrile Subject at 4 Hours Following Treatment

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 27, 2009
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.