Post-operative Oral Morphine Versus Ibuprofen

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01686802

Enrollment

132

Registered

2012-09-18

Start date

2012-09-30

Completion date

2016-09-30

Last updated

2016-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Keywords

oral morphine, ibuprofen, post-operative pain

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.

Interventions

DRUGoral morphine

DRUGIbuprofen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in faces pain score pre and post intervention	48 hours from the time of discharge from hospital.

Secondary

Measure	Time frame	Description
Change in faces pain score pre and post intervention	48 hours from the time of discharge from hospital	Second to eighth doses of intervention
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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026