Oral Versus Rectal Ibuprofen for Fever in Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adding a Second Drug for Febrile Children Treated With Acetaminophen

NCT00389272

Fever

UNKNOWN NA

Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever

NCT04123717

Fever

COMPLETED EARLY_PHASE1

Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

NCT00267293

Fever

COMPLETED PHASE4

Prescription Antipyretics to Decrease Unscheduled Return Visits In A Pediatric Emergency Department

NCT07074912

Fever

RECRUITING NA

Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

NCT01099462

Fever

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Ibuprofen Suppository

Group Type EXPERIMENTAL

Ibuprofen suppository

Intervention Type DRUG

5-10mg/Kg of ibuprofen

2

Ibuprofen suspension

Group Type ACTIVE_COMPARATOR

Ibuprofen Suspension

Intervention Type DRUG

5-10mg/Kg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibuprofen suppository

5-10mg/Kg of ibuprofen

Intervention Type DRUG

Ibuprofen Suspension

5-10mg/Kg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No