Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 5, 2011
March 1, 2010
2.2 years
August 6, 2008
April 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal change in temperature during the 4-hour period after enrollment.
4 hours
Secondary Outcomes (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.
4 h
Study Arms (2)
1
EXPERIMENTALIbuprofen Suppository
2
ACTIVE COMPARATORIbuprofen suspension
Interventions
Eligibility Criteria
You may qualify if:
- Age: 3 mo- 4 years
- Weight 6 - 18 kg
- Rectal temperature \> 38.50
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 6, 2008
First Posted
August 8, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
April 5, 2011
Record last verified: 2010-03