Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02064894
• Date of registration: 14/02/2014
• Prospective Registration: No
• Primary sponsor: St. Justine's Hospital
• Public title: Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries
• Scientific title: A Randomized Controlled Trial of Oral Analgesic Utilization for Pain Management of CHildhood Musculoskeletal Injuries
• Date of first enrolment: July 8, 2013
• Target sample size: 501
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02064894
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Sylvie Le May, PhD
• Affiliation: St. Justine's Hospital

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Musculoskeletal Injury

Intervention(s)

Drug: Oral ibuprofen

Drug: Oral morphine

Drug: oral morphine and oral ibuprofen

Primary Outcome(s)

Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm [Time Frame: 60 minutes post-analgesia]

Secondary Outcome(s)

Serious Adverse Event - Side Effects and Serious Adverse Events [Time Frame: 60, 90 and 120 minutes]

Secondary ID(s)

MOP-125943

OUCH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/08/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02064894