Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00474721

Purpose

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
Pain	Drug: ibuprofen Drug: acetaminophen with codeine

Drug Information available for: Ibuprofen Codeine phosphate Dexibuprofen Migraleve Codeine Acetaminophen CT 2584

U.S. FDA Resources

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

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

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

Secondary Outcome 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 ]

Enrollment:	68
Study Start Date:	November 2002
Study Completion Date:	February 2004

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.

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474721

Locations

United States, California
Rady Children's Hospital
San Diego, California, United States, 92123

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Janet H Friday

UCSD, Dept of Pediatrics and Rady Children's Hospital

More Information

No publications provided

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

Keywords provided by University of California, San Diego:

child
pain
analgesics

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009