Upper Extremity Fractures Clinical Trial
Official title:
Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
Verified date | July 2014 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.
Status | Completed |
Enrollment | 183 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 17 Years |
Eligibility |
Exclusion Criteria: - patients with known hypersensitivity to either ibuprofen or morphine - chronic users of NSAIDS or opioids - fractures requiring operative management - associated injuries requiring analgesia - poor English fluency - pregnancy Inclusion Criteria: - All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture |
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 | London Health Sciences Center | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Naveen Poonai |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Faces Pain scale - revised | The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs. | 30 minutes post intervention compared to baseline | No |
Secondary | Acetaminophen doses | The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management | 24 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT02366221 -
Upper-Extremity Bone or Joint Surgery: Long Term Outcome
|