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

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

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Drug: ibuprofen; Drug: acetaminophen

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20060
      • Howard University
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital (U. Miami)
    • Orlando, Florida, United States, 32804
      • Florida Hospital
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Joseph M. Still Burn Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121-2483
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • New York
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • The Children's Hospital at Saint Francis
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • LeBonheur Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • Children's Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
2. Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
3. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ibuprofen; Ibuprofen, 10 mg/kg	Drug: ibuprofen; Ibuprofen, 10 mg/kg
ACTIVE_COMPARATOR: Acetaminophen; Acetaminophen, 10mg/kg	Drug: acetaminophen; Acetaminophen, 10mg/kg; Other Names: paracetamol; APAP (acetaminophen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever Reduction	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)	0 to 2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Temperature After the First 30 Minutes of Treatment	Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.	30 minutes following treatment
Change From Baseline in Temperature After the First 60 Minutes of Treatment	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.	60 minutes following treatment
Change in Temperature	Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.	4 hours following treatment
Change From Baseline in Temperature After the First Four Hours of Treatment	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)	0 to 4 hours post-dose
Time to Afebrility (in Hours)	Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.	4 Hour post treatment
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose	Number of Afebrile and Febrile Subject at 4 Hours Following Treatment	4 Hours Post-Dose

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Study Director: Art Wheeler, M.D., Cumberland Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (ESTIMATE): October 27, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Pediatric; Fever
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: CPI-CL-012