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Post-operative Oral Morphine Versus Ibuprofen

NCT ID: NCT01686802

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-operative Pain

Keywords

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oral morphine ibuprofen post-operative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ibuprofen

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.

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

oral morphine

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.

Group Type ACTIVE_COMPARATOR

oral morphine

Intervention Type DRUG

Interventions

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oral morphine

Intervention Type DRUG

Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Naveen Poonai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naveen Poonai, MSc MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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London Health Science Center

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 29018084 (View on PubMed)

Other Identifiers

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102923

Identifier Type: -

Identifier Source: org_study_id