CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 501 enrolled
Drug / intervention
oral morphine and oral ibuprofen +2 moredrug
Likely dose
Oral morphine 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02064894
NCT02064894N/ACompleted

A Randomized Controlled Trial of Oral Analgesic Utilization for Pain Management of CHildhood Musculoskeletal Injuries

St. Justine's Hospital·interventional·Posted Feb 17, 2014·Updated Aug 3, 2017

In Brief

A clinical study evaluating oral morphine and oral ibuprofen, Oral morphine, and 1 other intervention for Musculoskeletal Injury. Completed, enrolled 501 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2014
Enrollment StartJul 8, 2013
Primary CompletionJun 22, 2015
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.4 years ago

Interventions

oral morphine and oral ibuprofendrug

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

Oral morphinedrug

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

Oral ibuprofendrug

oral ibuprofen combine to a placebo is the active comparator