Pain Assessment in Children Undergoing Spine Surgery
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 01/09/2020 |
| Estimated Enrollment Submitted: | 01/23/2020 |
| First Posted: | 01/27/2020 |
| Last Update Submitted: | 01/23/2020 |
| Last Update Posted: | 01/27/2020 |
| Actual Study Start Date: | 12/31/2014 |
| Estimated Primary Completion Date: | 12/31/2021 |
| Estimated Study Completion Date: | 06/30/2022 |
Condition or disease
Intervention/treatment
Behavioral: Verbal Patients
Behavioral: Non-verbal Patients
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Verbal Patients | Behavioral: 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. |
| Active Comparator: Non-verbal Patients | Behavioral: 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. |
Eligibility Criteria
| Ages Eligible for Study | 10 Years To 10 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Aged between 10 and 21 years old - Scheduled to undergo posterior or anterior spinal fusion surgery for AIS with instrumentation - Ability to adequately understand and respond to outcome measures - No previous major orthopedic surgery - Female or male - Any ethnic background Exclusion Criteria: - Inability of the child to speak English or French - Diagnosed with developmental delay that would interfere with understanding questions being asked (autism, mental retardation) - Children with major chronic medical conditions (ASA status III or higher) |
Outcome
Primary Outcome Measures
1. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [Baseline]
2. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [Postoperative day 1]
3. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [Postoperative day 2]
4. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [Postoperative day 5]
5. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [6 weeks postoperative]
6. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [6 months postoperative]
7. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [1 year postoperative]
8. Pain intensity as assessed by the The Faces Pain Scale -Revised (0-10 scale, with higher score indicating more pain) in verbal patients [2 years postoperative]
9. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [Baseline]
10. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [Postoperative day 1]
11. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [Postoperative day 2]
12. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [Postoperative day 5]
13. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [6 weeks postoperative]
14. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [6 months postoperative]
15. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [1 year postoperative]
16. Pain intensity as assessed by the Non-Communicating Children's Pain Checklist-Revised (NCCPC-R), and its post-operative version in non-verbal patients, with higher score indicating more pain [2 years postoperative]
Secondary Outcome Measures
1. Mechanical detection threshold (grams) as measured with von Frey filaments [Baseline]
2. Pain pressure threshold (Newtons) as measured with an algometer. [Baseline]
3. Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. [Baseline]
4. Mechanical detection threshold (grams) as measured with von Frey filaments [Postoperative day 1]
5. Pain pressure threshold (Newtons) as measured with an algometer. [Postoperative day 1]
6. Mechanical detection threshold (grams) as measured with von Frey filaments [Postoperative day 2]
7. Pain pressure threshold (Newtons) as measured with an algometer. [Postoperative day 2]
8. Mechanical detection threshold (grams) as measured with von Frey filaments [Postoperative day 5]
9. Pain pressure threshold (Newtons) as measured with an algometer. [Postoperative day 5]
10. Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. [Postoperative day 5]
11. Mechanical detection threshold (grams) as measured with von Frey filaments [6 weeks postoperative]
12. Pain pressure threshold (Newtons) as measured with an algometer. [6 weeks postoperative]
13. Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. [6 weeks postoperative]
14. Mechanical detection threshold (grams) as measured with von Frey filaments [6 months postoperative]
15. Pain pressure threshold (Newtons) as measured with an algometer. [6 months postoperative]
16. Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. [6 months postoperative]
17. Mechanical detection threshold (grams) as measured with von Frey filaments [1 year postoperative]
18. Pain pressure threshold (Newtons) as measured with an algometer. [1 year postoperative]
19. Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. [1 year postoperative]
20. Mechanical detection threshold (grams) as measured with von Frey filaments [2 years postoperative]
21. Pain pressure threshold (Newtons) as measured with an algometer. [2 years postoperative]
22. Conditioned pain modulation (CPM) efficiency, a physiological parameter calculated as the percentage difference between the average pain intensity (0-10) reported during a thermode (heat) test before and after a cold water submersion bath test. [2 years postoperative]
23. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [Baseline]
24. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [Postoperative day 1]
25. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [Postoperative day 2]
26. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [Postoperative day 5]
27. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [6 weeks postoperative]
28. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [6 months postoperative]
29. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [1 year postoperative]
30. Total Score of the Pain Catastrophizing Scale (0-52). Higher scores indicate higher levels of pain-related anxiety. [2 years postoperative]
31. Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). [Baseline]
32. Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). [6 weeks postoperative]
33. Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). [6 months postoperative]
34. Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). [1 year postoperative]
35. Total score (30-150) across to 4 domains of the Scoliosis Research Society Questionnaire-30 (SRS-30) regarding the outcome of the patient's spine surgery (items scored from 1=worst, to 5=best, thus lower scores mean worse outcomes). [2 years postoperative]
36. Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. [Baseline]
37. Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. [6 weeks postoperative]
38. Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. [6 months postoperative]
39. Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. [1 year postoperative]
40. Total Score of the Functional Disability Inquiry (0-60). Higher scores indicate greater activity limitations during the past 2 weeks. [2 years postoperative]
41. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. [Baseline]
42. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. [Baseline]
43. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. [Day of surgery]
44. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. [Day of surgery]
45. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. [6 weeks postoperative]
46. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. [6 weeks postoperative]
47. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. [6 months postoperative]
48. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. [6 months postoperative]
49. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. [1 year postoperative]
50. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. [1 year postoperative]
51. Score of State Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater state anxiety. [2 years postoperative]
52. Score of Trait Anxiety of the State-Trait Anxiety Scale (20-60). Higher scores indicate greater trait anxiety. [2 years postoperative]
53. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [Baseline]
54. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [Postoperative day 1]
55. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [Postoperative day 2]
56. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [Postoperative day 5]
57. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [6 weeks postoperative]
58. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [6 months postoperative]
59. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [1 year postoperative]
60. Score on Activity Avoidance and Somatic Function of the Tampa Scale for Kinesiophobia (score 17-68). Higher scores indicate greater kinesiophobia. [2 years postoperative]
61. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [Baseline]
62. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [Postoperative day 1]
63. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [Postoperative day 2]
64. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [Postoperative day 5]
65. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [6 weeks postoperative]
66. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [6 months postoperative]
67. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [1 year postoperative]
68. Global Score of the Pittsburgh Sleep Quality Index (0-21). Higher scores indicate a worse sleep quality (>5 indicates "poor sleeper"). [2 years postoperative]
