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

Fever research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fever

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ibuprofen suppository5-10mg/Kg of ibuprofen

Drug:Ibuprofen Suspension5-10mg/Kg

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Ibuprofen Suppository

2Ibuprofen suspension

Study Status

Unknown status

Start Date: September 2008

Completed Date: June 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Maximal change in temperature during the 4-hour period after enrollment.

Secondary Outcome: 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.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Assaf-Harofeh Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00729976

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