Post-operative Oral Morphine Versus Ibuprofen

Lawson Health Research Institute

Status and phase: Completed; Phase 2

Conditions: Post-operative Pain

Treatments: Drug: Ibuprofen; Drug: oral morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01686802

102923

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

ibuprofen

Active Comparator group

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.

Treatment:

Drug: Ibuprofen

oral morphine

Active Comparator group

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.

Treatment:

Drug: oral morphine