A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

MSK-I is the most common cause for ED visits for children with pain, with a child's risk of sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate moderate to severe pain in most children and the ED serves as the critical entry point for these injured children. This study aims to provide rapid and sustained pain management for children presenting with a MSK-I in the ED. The investigators will compare the efficacy of 2 possible medication combinations (fentanyl intranasal + oral hydromorphone or fentanyl intranasal + oral ibuprofen) for the rapid, adequate and sustained pain management of children with suspected fracture.

The investigators believe that the addition of HM to INF will lead to better pain treatment by providing a consistent and adequate level of analgesia throughout the entire ED visit, including prior to physician exam and during painful radiologic procedures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Justine's Hospital
• Treatments: Analgesics; Fentanyl; Hydromorphone; Ibuprofen

Criteria

Inclusion Criteria:

• pain score >49 mm on the VAS at triage

• between the ages of 8 and 17 years

• presenting to the ED with a suspected fracture of the upper of lower limb

• who can communicate in either French or English

Exclusion Criteria:

• known allergy to fentanyl, hydromorphone, ibuprofen, or artificial colouring

• triage nurse suspicion of child abuse

• inability to self-report pain

• chronic pain that necessitates daily analgesic use

• NSAID or opioid use within the three hours prior to ED presentation

• trauma to >1 limb

• known hepatic or renal disease/dysfunction

• known bleeding disorder

• neuro-cognitive disability that precludes assent and/or participating in the study

• known history of obstructive sleep apnea

• a suspected fracture of the nose

• significant head injury, as determined by the clinical team/triage nurse.