Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Overview

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.

Full Title of Study: “A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

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.

Interventions

  • Drug: ibuprofen
  • Drug: acetaminophen with codeine

Clinical Trial Outcome Measures

Primary Measures

  • Change in color analog scale pain score
    • Time Frame: 40 minutes

Secondary Measures

  • adverse reaction
    • Time Frame: during ED stay
  • need for rescue medication
    • Time Frame: during ED stay
  • Change in pain score
    • Time Frame: 20 and 60 minutes

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Overall Official(s)
    • Janet H Friday, Principal Investigator, UCSD, Dept of Pediatrics and Rady Children’s Hospital

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