A Study of Non-Steroidal or Opioid Analgesia Use for Children with Acute Musculoskeletal Injuries: The No OUCH Trials


OVERVIEW

Status: Recruitment Complete
ClinicalTrials.Gov Identifier: NCT03767933
Principal Investigator: Dr. Samina Ali
Project Manager: Patricia Candelaria

STUDY HIGHLIGHT

  1. This study will help figure out the best pain medicines to use when treating children with broken bones

  2. Children's pain is almost universally under-treated, and studies like this will help address that

  3. This project is using a newly-created study design, the Preference-Informed Complementary Trial Design, to make sure that families are empowered in the research process

POPULATION

536 children, aged 6-17 years, presenting to one of six Canadian pediatric emergency departments with an acute MSK injury (<24 hours old) of a single limb.

OBJECTIVE

The objective of this study is to determine the effectiveness and safety of a combination of opioid and non-opioid oral analgesic medications (PO ibuprofen+ PO acetaminophen; PO ibuprofen + PO hydromorphone; PO ibuprofen alone) for the pain management of children with an acute MSK limb injury.

STUDY DESIGN