Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study. - Full Text View

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00729976

Purpose

Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel.

All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.

Condition	Intervention	Phase
Fever	Drug: Ibuprofen suppository Drug: Ibuprofen Suspension	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

Maximal change in temperature during the 4-hour period after enrollment. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at 4h. Decrement in fever at each time point, and the area under the temperature (versus time) curve. Proportion of patients with temperature < 38 at 4 hours. [ Time Frame: 4 h ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ibuprofen Suppository	Drug: Ibuprofen suppository 5-10mg/Kg of ibuprofen
2: Active Comparator Ibuprofen suspension	Drug: Ibuprofen Suspension 5-10mg/Kg

Eligibility

Ages Eligible for Study:	3 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age: 3 mo- 4 years

Weight 6 - 18 kg
Rectal temperature > 38.50

Exclusion Criteria:

Treatment with acetaminophen in the last 4 hours
Treatment with Ibuprofen in the last 6 hours
Unable to take oral or rectal medications
Hypersensitivity to ibuprofen
Renal failure
Liver disease
Rectal temperature can't be measured (due to anatomical or medical problem)
Informed consent could not be granted

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729976

Contacts

Contact: Eran Kozer, MD	972 8 9779916	erank@asaf.health.gov.il
Contact: Ehud Rosenbloom, MD	972 8 9779916	ehudroze@gmail.com

Locations

Israel
Assaf Harofeh
Zerifin, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

More Information

No publications provided

Responsible Party:	Assaf-Harofeh Medical Center ( Eran Kozer )
Study ID Numbers:	091/08
Study First Received:	August 6, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00729976 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

Ibuprofen
Suppository
febrile children

Study placed in the following topic categories:

Anti-Inflammatory Agents
Fever
Signs and Symptoms
Ibuprofen
Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Body Temperature Changes
Pharmacologic Actions
Fever

Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009