Musculoskeletal Injury Clinical Trial
Official title:
A Randomized Controlled Trial of Oral Analgesic Utilization for Pain Management of CHildhood Musculoskeletal Injuries
Verified date | December 2015 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Canadian Institutes of Health Research |
Study type | Interventional |
Pain management for children presenting to the emergency department (ED) with an injured
limb is often under-treated, even though it is known that broken arms and legs cause
moderate to severe pain. Further, children are less likely to receive appropriate pain
medicine than adults with similar injuries. This study aims to improve the pain treatment of
children who present to the ED with a suspected fracture, or broken bone or severe sprain.
The investigators will compare the use of 3 different possible medication combinations
(ibuprofen alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine
which combination is the best at treating children's pain. The investigators also plan to
verify the safety of using these different drugs to treat children's pain.
The investigators strongly believe that children's pain should be optimally treated in the
ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have
both short and longterm effects on the child. It also generates unnecessary stress for both
the child and their caregivers/parents. Given this knowledge, the investigators feel that
their study has the potential to impact care provided in EDs, and improve pain management
safely, for children.
Status | Completed |
Enrollment | 501 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Between the ages of 6 and 17 years - Presenting to the ED with a musculoskeletal (MSK) trauma to either of the upper or lower limbs that is neither obviously deformed, nor neurovascularly compromised - Self-reported pain score >29 mm on a 0 to 100mm Visual Analogue Scale (VAS) - Able to understand French or English. Exclusion Criteria: - Known allergy to morphine, ibuprofen, or artificial colouring - MSK trauma that are suspected to be due to child abuse, as determined by the triage nurse - Inability to self-report pain - Chronic pain issues that require daily analgesic use - NSAID or opioid analgesic use within three hours prior to presentation to triage (Exception of acetaminophen) - Trauma to more than one limb (except fingers and toes) - Known hepatic or renal disease/dysfunction - Known bleeding disorder - Neuro-cognitive disability that precludes patients from assenting and participating to the study. - Known history of snoring consistently for the past 5 nights |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Canada | St.Justine's Hospital | Montreal | Quebec |
Canada | Children Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | To verify if pain intensity has decreased 60 minutes after the administration of analgesia | 60 minutes post-analgesia | No |
Secondary | Serious adverse event | To verify the occurence of any serious adverse event, such as respiratory depression or deep sedation, during all the time-periods of the study | 60, 90 and 120 minutes | Yes |
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