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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 4

Conditions: Fever

Treatments: Drug: Ibuprofen suppository; Drug: Ibuprofen Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT00729976

091/08

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

1

Experimental group

Description:

Ibuprofen Suppository

Treatment:

Drug: Ibuprofen suppository

2

Active Comparator group

Description:

Ibuprofen suspension

Treatment:

Drug: Ibuprofen Suspension