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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: August 8, 2008
Last Update Posted: April 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Resource links provided by NLM:

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 ]

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 ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ibuprofen Suppository
Drug: Ibuprofen suppository
5-10mg/Kg of ibuprofen
Active Comparator: 2
Ibuprofen suspension
Drug: Ibuprofen Suspension


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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729976

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

Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Eran Kozer, MD    97289779916    erank@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Responsible Party: Eran Kozer, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00729976     History of Changes
Other Study ID Numbers: 091/08
First Submitted: August 6, 2008
First Posted: August 8, 2008
Last Update Posted: April 5, 2011
Last Verified: March 2010

Keywords provided by Assaf-Harofeh Medical Center:
febrile children

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action