Acute Pediatric Fracture Analgesia Study
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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 |
- Change to rescue medication [ Time Frame: First 72 hours after ED discharge ]
- 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:
|
| 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 |
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| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53201 | |
| 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 May 16, 2013