Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

NCT00267293 | Completed Phase 4 Results

• 1 other identifier: HY03-127
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.

Conditions

Fever

Keywords

fever treatment; children

Outcome Measures

Primary Outcomes (1)

• Child Temperature (Degrees C)Over 6 Hours

  Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.

  6 hours

Study Arms (3)

A

ACTIVE COMPARATOR

At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg)

Drug: Ibuprofen

B

EXPERIMENTAL

At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and an appropriate dose of Acetaminophen (15 mg/kg)

Drug: Acetaminophen; Drug: Ibuprofen

C

EXPERIMENTAL

At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and at time 3 hours is given an appropriate dose of Acetaminophen (15 mg/kg)

Drug: Acetaminophen; Drug: Ibuprofen

Interventions

Acetaminophen DRUG

Given for fever control 15mg/kg

B; C

Ibuprofen DRUG

Given for fever control 10 mg/kg

A; B; C

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months - 7 years of age at time of the fever.
• Initial temperature of 38.0C (100.4F) or more.
• Ability to cooperate with serial temporal artery temperature measurements.
• Ability to take medications by mouth.
• Willingness of the child's guardian/sponsor to give informed consent

You may not qualify if:

• Patients who have received acetaminophen within 6 hours of presentation, or ibuprofen, aspirin, or other non-steroidal anti-inflammatory medications within 8 hours of presentation.
• Patients \>=3 years of age that have received narcotics in the previous 24 hours.
• Children with weight \>60 kg. Treatment of children with weights \>60 kg will result in greater than recommended adult doses of the medications.
• History of adverse reaction to any study medication ingredient.
• History of diabetes mellitis, renal dysfunction, hepatic dysfunction, or thrombocytopenia.
• Presence of moderate or severe dehydration.

Sponsors & Collaborators

• Penn State University: lead
• Children Youth and Family Consortium: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Related Publications (1)

• Paul IM, Sturgis SA, Yang C, Engle L, Watts H, Berlin CM Jr. Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children. Clin Ther. 2010 Dec;32(14):2433-40. doi: 10.1016/j.clinthera.2011.01.006.

  PMID: 21353111 DERIVED

Related Links

• Penn State Milton S. Hershey Children's Hospital Pediatric Clinical Research Office

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

Relatively small sample size. Underpowered to evaluate effect oon discomfort and pain. The 6 hour observation allowed for evaluation of single cycle of drug. Did not evaluate the effect of multiple doses over a longer observation period.

Results Point of Contact

• Title: Ian M Paul, MD, MSc
• Organization: Penn State Children's Hospital

ipaul@hmc.psu.edu

717-531-5656

Study Officials

• Ian M Paul, MD

  Penn State Milton S. Hershey Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Public Health Sciences

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 20, 2005
• Study Start: January 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 9, 2012
• Results First Posted: May 9, 2012

Record last verified: 2012-05

Locations

US (1)