Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries (No OUCH)
Musculoskeletal Injury
About this trial
This is an interventional treatment trial for Musculoskeletal Injury focused on measuring Pediatrics, Emergency, Analgesia, Opioids, Combination therapy, Ibuprofen, Acetaminophen, Hydromorphone
Eligibility Criteria
Inclusion Criteria:
- Child aged 6-17 years
- 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)
- Self-reported pain score > 5 on the 0 to 10 verbal Numerical Rating Scale at triage
Exclusion Criteria:
- Deemed to require immediate intravenous (IV) or intranasal (IN) pain medications by the clinical team
- Previously known hypersensitivity to study medications
- Acetaminophen or NSAID use within 3 hours prior to recruitment
- Opioid use within 1 hour prior to recruitment
- Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions
- Injury suspected to be due to non-accidental trauma/ child abuse (as assessed by the triage nurse or reported by the family)
- Suspected multi-limb fracture
- Chronic pain that necessitates daily analgesic use
- Hepatic or renal disease/dysfunction
- Bleeding disorder
- Known pregnancy
- Vomiting that precludes the ability to take oral medications (as determined by the family)
- Caregiver and/or child inability to communicate fluently in English or French in the absence of a native language interpreter
- Caregiver unavailable for follow-up
- Previous enrolment in the NO OUCH study
Sites / Locations
- Alberta Children's Hospital
- Stollery Children's Hospital Emergency Department
- Children's Hospital of Winnipeg
- Childrens Hospital at London Health Sciences
- Children's Hospital of Eastern Ontario
- CHU Sainte-Justine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Non-Opioid Trial: Arm 1
Non-Opioid Trial: Arm 2
Opioid Trial: Arm 1
Opioid Trial: Arm 2
Opioid Trial: Arm 3
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo, both administered once during the study at the time of recruitment.
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen (15mg/kg, maximum 1000mg), both administered once during the study at the time of recruitment.
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo + Oral hydromorphone placebo, all administered once during the study at the time of recruitment.
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen (15mg/kg, maximum 1000mg) + Oral hydromorphone placebo, all administered once during the study at the time of recruitment.
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo + Oral hydromorphone (0.05mg/kg, maximum 5 mg), all administered once during the study at the time of recruitment.