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Oral Morphine Versus Ibuprofen

Primary Purpose

Upper Extremity Fractures, Analgesia Post Fracture

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oral morphine
Ibuprofen
Sponsored by
Naveen Poonai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Extremity Fractures focused on measuring fracture, pediatric, oral morphine, ibuprofen

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • London Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ibuprofen

Oral morphine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2012
Last Updated
July 15, 2014
Sponsor
Naveen Poonai
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1. Study Identification

Unique Protocol Identification Number
NCT01690780
Brief Title
Oral Morphine Versus Ibuprofen
Official Title
Oral Morphine Versus Ibuprofen for Post-fracture Pain Management in Children: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Naveen Poonai

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Fractures, Analgesia Post Fracture
Keywords
fracture, pediatric, oral morphine, ibuprofen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Title
Oral morphine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oral morphine
Intervention Description
oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
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
Primary Outcome Measure Information:
Title
Faces Pain scale - revised
Description
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.
Time Frame
30 minutes post intervention compared to baseline
Secondary Outcome Measure Information:
Title
Acetaminophen doses
Description
The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveen Poonai, MD, FRCPC
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25349008
Citation
Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.
Results Reference
derived

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Oral Morphine Versus Ibuprofen

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