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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 because the information has not been verified recently.
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00729976
First received: August 6, 2008
Last updated: April 4, 2011
Last verified: March 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Fever
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: 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
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 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

No publications provided

Responsible Party: Eran Kozer, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00729976     History of Changes
Other Study ID Numbers: 091/08
Study First Received: August 6, 2008
Last Updated: April 4, 2011
Health Authority: Israel: Ministry of Health

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013