Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries
Status:
Recruiting
Trial end date:
2023-09-15
Target enrollment:
Participant gender:
Summary
Musculoskeletal (MSK) injuries, including limb injuries, are the most common cause for
Emergency Department (ED) visits for children with pain. Broken arms and legs are known to
cause moderate to severe pain in most children, yet previous research shows that children's
pain in the emergency department is still under-treated. Further, children are less likely to
receive appropriate pain medicine than adults with similar injuries.
The purpose of this research study is to compare the effectiveness and safety of 3 different
possible medication combinations, for the pain management of children with acute MSK limb
injuries. The pain medicines the investigators are studying are ibuprofen (Advil/Motrin),
acetaminophen (Tylenol/Tempra), and hydromorphone (Dilaudid).
This study will consist of 2 trials that will be run simultaneously. Eligible caregiver/
child pairs presenting to the emergency department with acute MSK limb injury will decide in
which trial they wish to participate: the Opioid trial or the Non-Opioid trial. If they
select the Non-opioid trial, they will have an equal chance of receiving either (a) Ibuprofen
OR (b) Ibuprofen and acetaminophen. If they select the Opioid trial, they will have an equal
chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen OR (c) Ibuprofen
and hydromorphone. Regardless of which study they choose, their child will, at minimum,
receive Ibuprofen (Advil/Motrin) for their pain. All study medicines will be given in oral
liquid form.
This study will help the investigators figure out which pain medicine or combination of pain
medicines works best for children with limb injuries. Promotion of adequate acute pain
treatment of children presenting to the ED may help prevent the known short and long-term
effects of inadequately treated pain in children, including unpleasant memories, stress and
anxiety upon future visits to healthcare, and compromised functional outcomes such as missed
school.