Combined Analgesia to Control Pain in Children Seen in Emergency Department (ED) for a Trauma of a Limb
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
1 other identifier
interventional
200
1 country
1
Brief Summary
Prospective study to evaluate the additive value of codeine on ibuprofen in the management of pediatric patient with a trauma of a limb.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedAugust 27, 2010
May 1, 2010
1.7 years
May 11, 2010
August 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain level on Verbal Analogue Scale (VAS) 60 minutes post administration of meds
60 minutes
Secondary Outcomes (2)
pain level on Verbal Analogue Scale (VAS) 120 minutes post study meds
120 minutes
side-effects of study meds
120 minutes
Study Arms (2)
1
EXPERIMENTALIbuprofen given orally (10 mg/kg, max = 600 mg) and codeine given orally (1 mg/kg, max = 60 mg).
2
PLACEBO COMPARATORIbuprofen given orally (10 mg/kg, max = 600 mg) and placebo given orally ( identical in taste color to codeine preparation).
Interventions
ibuprofen: 10 mg/kg (max = 600 mg), codeine: 1 mg/kg (max = 60 mg)
Eligibility Criteria
You may qualify if:
- to 18 years
- VAS \> 3/10
- Recent trauma (previous 24 hours)
You may not qualify if:
- Allergy
- Asthma exacerbation
- Critical state
- Physical abuse
- Severe developmental delay
- Recent analgesia (previous 6 hours)
- Significant other trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Ste-Justine
Montreal, Quebec, H3T1C5, Canada
Related Publications (1)
Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
PMID: 32797734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Le May, PhD
St. Justine's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 11, 2010
First Posted
August 27, 2010
Study Start
February 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 27, 2010
Record last verified: 2010-05