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Sponsored by: |
University of California, San Diego |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00474721 |
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 | Intervention |
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Pain |
Drug: ibuprofen Drug: acetaminophen with codeine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries |
Enrollment: | 68 |
Study Start Date: | November 2002 |
Study Completion Date: | February 2004 |
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.
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Rady Children's Hospital | |
San Diego, California, United States, 92123 |
Principal Investigator: | Janet H Friday | UCSD, Dept of Pediatrics and Rady Children's Hospital |
Study ID Numbers: | RCHSD10926 |
Study First Received: | May 16, 2007 |
Last Updated: | May 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00474721 History of Changes |
Health Authority: | United States: Institutional Review Board |
child pain analgesics |
Anti-Inflammatory Agents Ibuprofen Cyclooxygenase Inhibitors Central Nervous System Depressants Pain Narcotics Codeine Naphazoline Analgesics, Non-Narcotic |
Guaifenesin Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Phenylpropanolamine Antirheumatic Agents Acetaminophen Analgesics, Opioid |
Anti-Inflammatory Agents Respiratory System Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Central Nervous System Depressants Enzyme Inhibitors Narcotics Codeine Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Antitussive Agents Central Nervous System Agents Acetaminophen Analgesics, Opioid |