NCT04244760

Pain Assessment in Children Undergoing Spine Surgery

Peri-operative Pain Assessment in Children Undergoing Orthopaedic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Catherine Ferland · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Musculoskeletal (MSK) pain is one of the most common types of pain among children and adolescents. Recurring episodes of MSK pain conditions have a major impact on the daily lives. Children and adolescents with neuromuscular diseases are often unable to report the pain the patients experience because of intellectual and/or physical limitations. There is no reason to believe that pain is any less frequent or intense in these patients than in normally developing patients. Because of the elusive nature of pain in non-verbal children, therapeutic decisions are frequently based on vague proxy measures of pain and revert to a series of trials and errors. This project creates a unique opportunity to directly characterize and compare MSK and surgical pain subjectively in two different patient samples (verbal and non-verbal). The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions, and more specifically in children with limited communication skills unable to communicate their distress associated with the surgical procedural.

Detailed description

Improvement in the assessment techniques, to enable better pain management in children with intellectual and developmental disabilities who are unable to describe the intensity of the postsurgical pain, is a cornerstone of our research program. This research project will elucidate the regulation of specific markers of global surgical insult (nociception, inflammation, stress responses) associated to specific physiological mechanisms related to pain in children with and without verbal skills undergoing major orthopaedic surgery. This project creates a unique opportunity to directly characterize and compare MSK and surgical pain subjectively in the two different patient samples (verbal and non-verbal). As molecular events of pathophysiological processes are quantifiable, the investigators will test for associations between the expression of front-running pain biomarkers in physiological fluids (blood and saliva) and the experience of pain in two patient samples (verbal and non-verbal) undergoing major orthopaedic surgery. The identification of biomarkers will provide a deeper understanding of a patient's pain perception alongside self-report or observers' report subjective measurements. Even with standardization of best practice perioperative anesthetic pain management, children undergoing similar surgical procedures experience pain at different intensity. Based on preliminary findings, treatment modalities appear to be ineffective in one out of five patients. Pain experience variability may originate in the lack of rigor in the clinical pain assessment tools. Tools such as numerical rating scales used in the perioperative period are not based on objective patient specific pain thresholds. A personalized mechanism-based approach may be the key to better identify a patient's postsurgical pain outcome and how this assessment could lead to personalized perioperative pain management. The ultimate goal is to use this information to offer the highest quality of pain control in children with MSK conditions, and more specifically in children with limited communication skills unable to communicate their distress associated with the surgical procedures.

Conditions

• Adolescent Idiopathic Scoliosis
• Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	Pain assessment for verbal patients	The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical and thermal), and psychological state via the completion of questionnaires by the patient.
BEHAVIORAL	Pain assessment for non-verbal patients	The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical), and psychological state via the completion of questionnaires by the parent of the patient.

Timeline

• Start date: 2015-01-01
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2020-01-28
• Last updated: 2022-05-04

Locations

1 site across 1 country: Canada