Oral Morphine Versus Ibuprofen

Upper Extremity Fractures Clinical Trial

Official title:

Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690780
• Other study ID #: R-11-340
• Secondary ID: 18091
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: July 15, 2014
• Start date: September 2012
• Est. completion date: February 2014

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia Post Fracture
• Fractures, Bone
• Upper Extremity Fractures

Intervention

Drug:
• Oral morphine
oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours
• Ibuprofen
Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Naveen Poonai

Country where clinical trial is conducted

Canada, 

Outcome

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