NCT01686802

Brief Summary

Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive management of fractures, tendon release, etc. will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in significantly lower pain scores on the Faces Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new option for post-operative pain management in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P75+ for phase_2 postoperative-pain

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2 postoperative-pain

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
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 28, 2016

Status Verified

December 1, 2016

Enrollment Period

4 years

First QC Date

September 13, 2012

Last Update Submit

December 27, 2016

Conditions

Post-operative Pain

Keywords

oral morphineibuprofenpost-operative pain

Outcome Measures

Primary Outcomes (1)

  • Change in faces pain score pre and post intervention

    48 hours from the time of discharge from hospital.

Secondary Outcomes (4)

  • Change in faces pain score pre and post intervention

    48 hours from the time of discharge from hospital

  • Adverse effects

    96 hours from first dose of intervention

  • Number of participants requiring acetaminophen for breakthrough pain

    48 hours from first dose of intervention

  • Unscheduled visits to a health care provider for pain

    96 hours from first dose of intervention

Study Arms (2)

ibuprofen

ACTIVE COMPARATOR

ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.

Drug: Ibuprofen

oral morphine

ACTIVE COMPARATOR

oral morphine 0.5 mg/kg (max 20 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.

Drug: oral morphine

Interventions

oral morphineDRUG
oral morphine
IbuprofenDRUG
ibuprofen

Eligibility Criteria

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

You may qualify if:

  • all children aged 5-17 years who undergo an elective orthopedic or fracture-related surgical procedure at the Children's Hospital in London, Ontario and have a same-day discharge.

You may not qualify if:

  • known hypersensitivity to either ibuprofen or morphine
  • chronic users of NSAIDS or opioids
  • cognitive impairment
  • poor English fluency
  • pregnancy
  • acute or chronic renal insufficiency
  • bleeding disorder
  • obstructive sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Science Center

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

  • Poonai N, Datoo N, Ali S, Cashin M, Drendel AL, Zhu R, Lepore N, Greff M, Rieder M, Bartley D. Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial. CMAJ. 2017 Oct 10;189(40):E1252-E1258. doi: 10.1503/cmaj.170017.

    PMID: 29018084DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineIbuprofen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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, MSc MD FRCPC

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 28, 2016

Record last verified: 2016-12

Locations

CA(1)