Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Pain Clinical Trial

Official title:

A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474721
• Other study ID #: RCHSD10926
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: May 16, 2007
• Start date: November 2002
• Est. completion date: February 2004

Study information

• Verified date: May 2007
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ibuprofen

• acetaminophen with codeine

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in color analog scale pain score		40 minutes
Secondary	adverse reaction		during ED stay
Secondary	need for rescue medication		during ED stay
Secondary	Change in pain score		20 and 60 minutes