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Completed

NCT Number: NCT00520442

Acute Pediatric Fracture Analgesia Study

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.

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

Other names: motrin, advil

acetamin w codeine

Drug

Other names: tylenol with codeine, T3

Primary outcomes

  1. Change to rescue medication

    Time frame: First 72 hours after ED discharge

Secondary outcomes

  1. Pain score

    Time frame: First 72 hours after ED discharge

  2. Functional outcomes: eat, sleep, play, school

    Time frame: First 72 hours after ED discharge

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

Registry information

Official study title

Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 24, 2007
Registry last updated
Mar 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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