Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries

• Status: Recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM); The Hospital for Sick Children; University of Calgary; University of Manitoba; University of Ottawa; University of Western Ontario, Canada
• Treatments: Acetaminophen; Analgesics, Opioid; Hydromorphone; Ibuprofen

Criteria

Inclusion Criteria:

1. Child aged 6-17 years

2. Presenting to the emergency department with an acute limb injury (<24 hours old) that is neither obviously deformed nor having neuro-vascular compromise (as assessed by the triage nurse)

3. Self-reported pain score > 5 on the 0 to 10 verbal Numerical Rating Scale at triage

Exclusion Criteria:

1. Deemed to require immediate intravenous (IV) or intranasal (IN) pain medications by the clinical team

2. Previously known hypersensitivity to study medications

3. Acetaminophen or NSAID use within 3 hours prior to recruitment

4. Opioid use within 1 hour prior to recruitment

5. Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions

6. Injury suspected to be due to non-accidental trauma/ child abuse (as assessed by the triage nurse or reported by the family)

7. Suspected multi-limb fracture

8. Chronic pain that necessitates daily analgesic use

9. Hepatic or renal disease/dysfunction

10. Bleeding disorder

11. Known pregnancy

12. Vomiting that precludes the ability to take oral medications (as determined by the family)

13. Caregiver and/or child inability to communicate fluently in English or French in the absence of a native language interpreter

14. Caregiver unavailable for follow-up

15. Previous enrolment in the NO OUCH study