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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

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

U.S. FDA Resources

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

ClinicalTrials.gov Identifier:	NCT00474721 History of Changes
Other Study ID Numbers:	RCHSD10926
Study First Received:	May 16, 2007
Last Updated:	May 16, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

child
pain
analgesics

Additional relevant MeSH terms:

Acetaminophen
Ibuprofen
Codeine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012