N/A
N=501
Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries
Musculoskeletal Injury
Bottom Line
View on ClinicalTrials.gov: NCT02064894 ↗Enrolled (actual)
501
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm — 33.0; 29.3; 29.9 Percentage of participants — p=0.81
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- oral morphine and oral ibuprofen (Drug); Oral morphine (Drug); Oral ibuprofen (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- St. Justine's Hospital
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm |
33.0; 29.3; 29.9 | 0.81 |
| SECONDARY Serious Adverse Event - Side Effects and Serious Adverse Events |
6; 39; 38; 0; 0; 0 | — |
Summary
Pain management for children presenting to the emergency department (ED) with an injured limb is often under-treated, even though it is known that broken arms and legs cause moderate to severe pain. Further, children are less likely to receive appropriate pain medicine than adults with similar injuries. This study aims to improve the pain treatment of children who present to the ED with a suspected fracture, or broken bone or severe sprain. The investigators will compare the use of 3 different possible medication combinations (ibuprofen alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine which combination is the best at treating children's pain. The investigators also plan to verify the safety of using these different drugs to treat children's pain.
The investigators strongly believe that children's pain should be optimally treated in the ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have both short and longterm effects on the child. It also generates unnecessary stress for both the child and their caregivers/parents. Given this knowledge, the investigators feel that their study has the potential to impact care provided in EDs, and improve pain management safely, for children.
Eligibility Criteria
Inclusion Criteria
- Between the ages of 6 and 17 years
- Presenting to the ED with a musculoskeletal (MSK) trauma to either of the upper or lower limbs that is neither obviously deformed, nor neurovascularly compromised
- Self-reported pain score >29 mm on a 0 to 100mm Visual Analogue Scale (VAS)
- Able to understand French or English.
Exclusion Criteria
- Known allergy to morphine, ibuprofen, or artificial colouring
- MSK trauma that are suspected to be due to child abuse, as determined by the triage nurse
- Inability to self-report pain
- Chronic pain issues that require daily analgesic use
- NSAID or opioid analgesic use within three hours prior to presentation to triage (Exception of acetaminophen)
- Trauma to more than one limb (except fingers and toes)
- Known hepatic or renal disease/dysfunction
- Known bleeding disorder
- Neuro-cognitive disability that precludes patients from assenting and participating to the study.
- Known history of snoring consistently for the past 5 nights
Data sourced from ClinicalTrials.gov (NCT02064894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.