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Post-operative Oral Morphine Versus Ibuprofen

Primary Purpose

Post-operative Pain

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

oral morphine

Ibuprofen

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring oral morphine, ibuprofen, post-operative pain

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

London Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ibuprofen

oral morphine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in faces pain score pre and post intervention

Secondary Outcome Measures

Change in faces pain score pre and post intervention

Second to eighth doses of intervention

Adverse effects

Number of participants requiring acetaminophen for breakthrough pain

Unscheduled visits to a health care provider for pain

Full Information

NCT ID

NCT01686802

First Posted

September 13, 2012

Last Updated

December 27, 2016

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01686802

Brief Title

Post-operative Oral Morphine Versus Ibuprofen

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Pain

Keywords

oral morphine, ibuprofen, post-operative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ibuprofen

Arm Type

Active Comparator

Arm Description

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.

Arm Title

oral morphine

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

oral morphine

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Primary Outcome Measure Information:

Title

Change in faces pain score pre and post intervention

Time Frame

48 hours from the time of discharge from hospital.

Secondary Outcome Measure Information:

Title

Change in faces pain score pre and post intervention

Description

Second to eighth doses of intervention

Time Frame

48 hours from the time of discharge from hospital

Title

Adverse effects

Time Frame

96 hours from first dose of intervention

Title

Number of participants requiring acetaminophen for breakthrough pain

Time Frame

48 hours from first dose of intervention

Title

Unscheduled visits to a health care provider for pain

Time Frame

96 hours from first dose of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naveen Poonai, MSc MD FRCPC

Organizational Affiliation

Lawson Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Science Center

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

29018084

Citation

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.

Results Reference

derived

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Post-operative Oral Morphine Versus Ibuprofen

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