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

Study Overview

• Status: Unknown
• Conditions: Fever
• Intervention / Treatment: Drug: Ibuprofen suppository; Drug: Ibuprofen Suspension

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eran Kozer, MD; Phone Number: 972 8 9779916; Email: erank@asaf.health.gov.il
• Study Contact Backup: Name: Ehud Rosenbloom, MD; Phone Number: 972 8 9779916; Email: ehudroze@gmail.com

Study Locations

• Israel
  • Zerifin, Israel, 70300
    • Recruiting
    • Assaf Harofeh Medical Center
    • Contact: Eran Kozer, MD; Phone Number: 97289779916; Email: erank@asaf.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal change in temperature during the 4-hour period after enrollment.	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: August 6, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): April 5, 2011
• Last Update Submitted That Met QC Criteria: April 4, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Ibuprofen; Suppository; febrile children
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 091/08