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Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries

NCT02064894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2017-08-03

Study results available
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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

Interventions

DRUG

oral morphine and oral ibuprofen

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

DRUG

Oral morphine

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

DRUG

Oral ibuprofen

oral ibuprofen combine to a placebo is the active comparator

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Sylvie Le May, PhD · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-08
Primary Completion
2015-06-22
Completion
2015-06-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064894 on ClinicalTrials.gov