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Combined Analgesia to Control Pain in Children Seen in Emergency Department (ED) for a Trauma of a Limb

This study has been completed.
Sponsor:
Information provided by:
St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01189773
First received: May 11, 2010
Last updated: August 26, 2010
Last verified: May 2010
History of Changes
  Purpose

Prospective study to evaluate the additive value of codeine on ibuprofen in the management of pediatric patient with a trauma of a limb.


Condition Intervention Phase
Trauma
 Drug: ibuprofen and codeine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Security of Combined Analgesia (Opioid and Anti-inflammatory Agent) to Control Pain in Children Seen in the Emergency Department for a Trauma of a Limb

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • pain level on Verbal Analogue Scale (VAS) 60 minutes post administration of meds [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain level on Verbal Analogue Scale (VAS) 120 minutes post study meds [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
  • side-effects of study meds [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ibuprofen given orally (10 mg/kg, max = 600 mg) and codeine given orally (1 mg/kg, max = 60 mg).
 Drug: ibuprofen and codeine
ibuprofen: 10 mg/kg (max = 600 mg), codeine: 1 mg/kg (max = 60 mg)
Other Name: advil, motrin
Placebo Comparator: 2
Ibuprofen given orally (10 mg/kg, max = 600 mg) and placebo given orally ( identical in taste color to codeine preparation).
 Drug: ibuprofen and codeine
ibuprofen: 10 mg/kg (max = 600 mg), codeine: 1 mg/kg (max = 60 mg)
Other Name: advil, motrin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 to 18 years
  • VAS > 3/10
  • Recent trauma (previous 24 hours)

Exclusion Criteria:

  • Allergy
  • Asthma exacerbation
  • Critical state
  • Physical abuse
  • Severe developmental delay
  • Recent analgesia (previous 6 hours)
  • Significant other trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189773

Locations
Canada, Quebec
CHU Ste-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Sylvie Le May, PhD CHU Ste-Justine
  More Information

No publications provided

Responsible Party: Sylvie Le May, CHU Ste-Justine
ClinicalTrials.gov Identifier: NCT01189773     History of Changes
Other Study ID Numbers: 2633
Study First Received: May 11, 2010
Last Updated: August 26, 2010
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
pain control
limb trauma

Additional relevant MeSH terms:
Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents
Ibuprofen
Codeine
Therapeutic Uses
Pharmacologic Actions
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013