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Acute Pediatric Fracture Analgesia Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520442
First Posted: August 24, 2007
Last Update Posted: March 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Medical College of Wisconsin
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00520442     History of Changes
Other Study ID Numbers: Fracture Pain
First Submitted: August 22, 2007
First Posted: August 24, 2007
Last Update Posted: March 7, 2008
Last Verified: March 2008

Keywords provided by Medical College of Wisconsin:
fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Ibuprofen
Codeine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents