Acute Pediatric Fracture Analgesia Study - Full Text View

Sponsor:	Medical College of Wisconsin
Collaborator:	Children's Hospital and Health System Foundation, Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00520442

Purpose

A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.

Condition	Intervention
Fracture	Drug: ibuprofen Drug: acetamin w codeine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Ibuprofen Codeine phosphate Codeine Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

Change to rescue medication [ Time Frame: First 72 hours after ED discharge ]

Secondary Outcome Measures:

Pain score [ Time Frame: First 72 hours after ED discharge ]
Functional outcomes: eat, sleep, play, school [ Time Frame: First 72 hours after ED discharge ]

Estimated Enrollment:	335
Study Start Date:	September 2003
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ibuprofen	Drug: ibuprofen Other Names: motrin advil
Active Comparator: acetamin w codeine	Drug: acetamin w codeine Other Name: tylenol with codeine, T3

Detailed Description:

A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. A random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. Descriptive statistics will be used to analyze demographic data.

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting

Exclusion Criteria:

A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520442

Locations

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201

Sponsors and Collaborators

Medical College of Wisconsin

Children's Hospital and Health System Foundation, Wisconsin

Investigators

Principal Investigator:

Amy L Drendel, DO

Medical College of Wisconsin

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00520442 History of Changes
Other Study ID Numbers:	Fracture Pain
Study First Received:	August 22, 2007
Last Updated:	March 6, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

fracture

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Codeine
Ibuprofen
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012