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Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

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ClinicalTrials.gov Identifier: NCT00474721
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : May 17, 2007
Sponsor:
Information provided by:
University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: ibuprofen Drug: acetaminophen with codeine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
Study Start Date : November 2002
Actual Study Completion Date : February 2004

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Primary Outcome Measures :
  1. Change in color analog scale pain score [ Time Frame: 40 minutes ]

Secondary Outcome Measures :
  1. adverse reaction [ Time Frame: during ED stay ]
  2. need for rescue medication [ Time Frame: during ED stay ]
  3. Change in pain score [ Time Frame: 20 and 60 minutes ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474721


Locations
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United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Janet H Friday UCSD, Dept of Pediatrics and Rady Children's Hospital

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ClinicalTrials.gov Identifier: NCT00474721     History of Changes
Other Study ID Numbers: RCHSD10926
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: May 17, 2007
Last Verified: May 2007
Keywords provided by University of California, San Diego:
child
pain
analgesics
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Codeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents