NCT00389272

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. Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. In order to achieve better temperature control and to avoid toxicity it has been suggested to treat febrile children with alternating doses of acetaminophen and ibuprofen. Surveys in the USA and Spain found that this practice is very common. However, The safety and efficacy of such practice was never described. Hypothesis: Children who are still febrile after being treated with acetaminophen or ibuprofen will have greater temperature decrement if treated with another drug (acetaminophen for those treated with ibuprofen and ibuprofen for those treated with acetaminophen) than if treated with placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2006

First QC Date

October 17, 2006

Last Update Submit

October 30, 2007

Conditions

Fever

Interventions

Ibuprofen, acetaminophenDRUG

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6 mo- 4 years
  • Rectal temperature \> 38.5
  • Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 - 3.5 hours before admission to the

You may not qualify if:

  • Received more than 75 mg acetaminophen in the last 24 hours
  • Unable to take oral medications
  • Hypersensitivity to acetaminophen or ibuprofen
  • Varicella
  • Renal failure
  • Liver disease
  • Rectal temperature can't be measured (due to anatomical or medical problem)
  • Received both Ibuprofen and acetaminophen in the last 6 hours
  • Informed consent could not be granted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Emergency Medicine Service, Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Fever

Interventions

IbuprofenAcetaminophen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Eran Kozer

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Kozer, MD

CONTACT

972 8 9779916erank@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

September 1, 2005

Study Completion

December 1, 2008

Last Updated

October 31, 2007

Record last verified: 2006-10

Locations

IL(1)