Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: ibuprofen (Drug); acetaminophen with codeine (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s): Janet H Friday, Principal Investigator, Affiliation: UCSD, Dept of Pediatrics and Rady Children's Hospital
Summary
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages
5-18 years who came to the Pediatric Emergency Department with injuries to their arms or
legs.
Clinical Details
Official title: A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change in color analog scale pain score
Secondary outcome: adverse reactionneed for rescue medication Change in pain score
Detailed description:
We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department
patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg
as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at
baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome
measured was the difference in changes in pain score at 40 minutes, compared against a
previously described minimal clinically significant change in pain score of 2 cm.
Additional outcomes included need for rescue medication and adverse effects.
Eligibility
Minimum age: 5 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 5 to 18 years of age
- Spoke English as a primary language
- Complained of an extremity injury with tenderness to palpation from the clavicle
or femoral neck to the distal phalanges
- Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at
triage
Exclusion Criteria:
- Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
- Administration of any analgesic within 6 hours of presentation;
- Significant deformity or vascular insufficiency of the extremity requiring immediate
treatment as determined by the treating physician;
- Inability to use the study pain instrument;
- Any laceration near the suspected injury;
- Chronic hepatic or renal disease;
- Pregnancy in the third trimester;
- Concurrent use of contraindicated medications such as monoamine oxidase inhibitors;
or
- Use of central nervous system depressants such as ethanol, benzodiazepines,
barbiturates, antidepressants, or recreational drugs
Locations and Contacts
Rady Children's Hospital, San Diego, California 92123, United States
Additional Information
Starting date: November 2002
Last updated: May 16, 2007
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