Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: ibuprofen
* Drug: acetaminophen with codeine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ibuprofen|nan|
|Drug: acetaminophen with codeine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in color analog scale pain score |  | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse reaction |  | during ED stay | 
| need for rescue medication |  | during ED stay | 
| Change in pain score |  | 20 and 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, pain, analgesics