Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries

NCT02064894 | Completed Results DMC

• 2 other identifiers: OUCHMOP-125943
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Musculoskeletal Injury

Keywords

children; analgesia; musculoskeletal injury; emergency; opioids

Outcome Measures

Primary Outcomes (1)

• Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm

  Percentage of participants which pain intensity has decreased under 30 mm on the VAS at 60 minutes. The Visual Analogue Scale is a 0 to 100 mm continuous scale measuring the pain intensity. Score of 0="No Pain"; Score of 100="Worst imaginable pain"

  60 minutes post-analgesia

Secondary Outcomes (1)

• Serious Adverse Event - Side Effects and Serious Adverse Events

  60, 90 and 120 minutes

Study Arms (3)

oral morphine and oral ibuprofen

EXPERIMENTAL

Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame

Drug: oral morphine and oral ibuprofen

morphine and placebo of ibuprofen

EXPERIMENTAL

Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study

Drug: Oral morphine

ibuprofen and placebo of morphine

ACTIVE COMPARATOR

Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study

Drug: Oral ibuprofen

Interventions

oral morphine and oral ibuprofen DRUG

The combination of oral morphine and oral ibuprofen is one of the Experimental arm group

oral morphine and oral ibuprofen

Oral morphine DRUG

Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study

morphine and placebo of ibuprofen

Oral ibuprofen DRUG

oral ibuprofen combine to a placebo is the active comparator

ibuprofen and placebo of morphine

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (3)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Children Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

St.Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

Location

Related Publications (1)

• Le May S, Ali S, Plint AC, Masse B, Neto G, Auclair MC, Drendel AL, Ballard A, Khadra C, Villeneuve E, Parent S, McGrath PJ, Leclair G, Gouin S; Pediatric Emergency Research Canada (PERC). Oral Analgesics Utilization for Children With Musculoskeletal Injury (OUCH Trial): An RCT. Pediatrics. 2017 Nov;140(5):e20170186. doi: 10.1542/peds.2017-0186. Epub 2017 Oct 11.

  PMID: 29021235 DERIVED

MeSH Terms

Conditions

Agnosia; Emergencies

Interventions

Morphine; Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

High attrition rate between the time of randomization and the 120 minutes following analgesic administration; The dose of oral morphine was within the recommended range, but higher doses have been used in other trials for MSK pain relief in children.

Results Point of Contact

• Title: Dr. Sylvie Le May
• Organization: CHU Ste-Justine Hospital

sylvie.lemay@umontreal.ca

514-343-6384

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: July 8, 2013
• Primary Completion: June 22, 2015
• Study Completion: June 22, 2015
• Last Updated: August 3, 2017
• Results First Posted: August 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)