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Completed

NCT Number: NCT01690780

Oral Morphine Versus Ibuprofen

Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.

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Key information

Conditions

Upper Extremity Fractures Analgesia Post Fracture Fractures, Bone Wounds and Injuries

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Center

London, Ontario, N6A5W9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • patients with known hypersensitivity to either ibuprofen or morphine
  • chronic users of NSAIDS or opioids
  • fractures requiring operative management
  • associated injuries requiring analgesia
  • poor English fluency
  • pregnancy

Inclusion criteria

  • All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Treatment and study plan

Oral morphine

Drug

oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours

Ibuprofen

Drug

Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department

Primary outcomes

  1. Faces Pain scale - revised

    Time frame: 30 minutes post intervention compared to baseline

    The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs.

Secondary outcomes

  1. Acetaminophen doses

    Time frame: 24 hours

    The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management

Sponsors and collaborators

Lead sponsor

Naveen Poonai

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2012
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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