NCT01690780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

September 13, 2012

Last Update Submit

July 15, 2014

Conditions

Upper Extremity FracturesAnalgesia Post Fracture

Keywords

fracturepediatricoral morphineibuprofen

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Acetaminophen doses

    24 hours

Study Arms (2)

Ibuprofen

ACTIVE COMPARATOR
Drug: Ibuprofen

Oral morphine

EXPERIMENTAL
Drug: Oral morphine

Interventions

Oral morphineDRUG

oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

Oral morphine
IbuprofenDRUG

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

Ibuprofen

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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
  • All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A5W9, Canada

Location

Related Publications (2)

  • Faught L, Elzagallaai AA, Tonial N, Ali S, Lepore N, Reardon J, Urquhart B, Ross C, Rieder MJ, Poonai N. Oral morphine pharmacokinetics in healthy children and the effect of genetic polymorphisms: An exploratory study. Paediatr Child Health. 2025 Oct 12;31(1):35-41. doi: 10.1093/pch/pxaf084. eCollection 2026 Feb.

    PMID: 41630937DERIVED

  • 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.

    PMID: 25349008DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

MorphineIbuprofen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Naveen Poonai, MD, FRCPC

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 24, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations

CA(1)