No OUCH Study

Study Summary

Musculoskeletal (MSK) injury is a very common cause for Emergency Department (ED) visits for children with pain. Although MSK injury is known to generate moderate to severe pain in most children, recent evidence confirms that pediatric pain management in the ED is still suboptimal. We have yet to identify the optimal acute pain management strategy for children with a suspected fracture, as very few studies of analgesic combination therapy for this injury exist, and monotherapy has been shown to be inadequate 50% of the time.

Our previous work has demonstrated that a combination of oral morphine with ibuprofen was no more effective and was less safe than oral ibuprofen, alone, for suspected fracture pain. Similarly, oxycodone was no more effective and was less safe than ibuprofen for post-discharge fracture pain. There is some emerging work from non-ED settings to suggest that oral hydromorphone may be an effective alternative to these two opioid medications. We wish to study if acetaminophen or hydromorphone, when added to ibuprofen, offers more clinical pain relief than ibuprofen alone. We also wish to study if the combination of hydromorphone and ibuprofen is more clinically effective than the combination of acetaminophen with ibuprofen.

Our study, which will consist of two clinical trials, will inform health-care decisions by providing evidence for the effectiveness and safety of commonly prescribed analgesic combination therapies, and compare them to the most commonly used monotherapy, ibuprofen

Objectives

1. To determine the effectiveness of a combination of opioid and non-opioid oral analgesic medications for the pain management of children with an acute MSK limb injury
2. To determine the proportion of children with adverse events related to study drug administration
3. To determine the proportion of children who require additional analgesia at 60 minutes post study drug administration
4. To determine caregiver reasons for choosing an opioid versus a non-opioid trial

Principal Study Investigator: Dr. Samina Ali

Leading Institution: Stollery Children's Hospital

PERT Site Investigator: Dr. Antonia Stang

PERT Site Research Coordinator: Kelly Kim

Study Team: Dr. Naveen Poonai, Manasi Rajagopal, Cathy Constable, Monica Adam, Dr. Amy Drendel, Dr. Christopher McCabe, Dr. Jennifer Thull-Freedman, Dr. Patrick McGrath, Dr. Timothy Graham, Dr. Lisa Hartling, Dr. Lawrence Richer, Pam Marples, Serena Hickes, Kurt Schreiner, Julie Leung, Dr. Scott Sawyer, Lise Bourrier, Kamary Coriolano DaSilva, Dr. Maala Bhatt, Lauren Dawson, Dr. Serge Gouin, Marie-Christine Auclair