DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Acute Pediatric Fracture Analgesia Study

Information source: Medical College of Wisconsin
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fracture

Intervention: ibuprofen (Drug); acetamin w codeine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Medical College of Wisconsin

Official(s) and/or principal investigator(s):
Amy L Drendel, DO, Principal Investigator, Affiliation: Medical College of Wisconsin

Summary

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.

Clinical Details

Official title: Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change to rescue medication

Secondary outcome:

Pain score

Functional outcomes: eat, sleep, play, school

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

Minimum age: 4 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: September 2003
Ending date: September 2007
Last updated: March 6, 2008

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014