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

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.
ClinicalTrials.gov Identifier: NCT00729976
Recruitment Status : Unknown
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : August 8, 2008
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Fever Drug: Ibuprofen suppository Drug: Ibuprofen Suspension Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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.
Study Start Date : September 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Ibuprofen Suppository
Drug: Ibuprofen suppository
5-10mg/Kg of ibuprofen
Active Comparator: 2
Ibuprofen suspension
Drug: Ibuprofen Suspension
5-10mg/Kg


Outcome Measures

Primary Outcome Measures :
  1. Maximal change in temperature during the 4-hour period after enrollment. [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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

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


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 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 Posted: August 8, 2008    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: March 2010

Keywords provided by Assaf-Harofeh Medical Center:
Ibuprofen
Suppository
febrile children

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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