Trial Outcomes & Findings for Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy (NCT NCT04074265)
NCT ID: NCT04074265
Last Updated: 2024-06-10
Results Overview
Average post-operative opioid consumption, measured in morphine equivalents per kilogram
COMPLETED
PHASE4
34 participants
During initial post-operative hospitalization (estimated 3-4 days)
2024-06-10
Participant Flow
Participant milestones
| Measure |
Pain Injection
This group will be injected with a cocktail totaling 50mL (25mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Ropivacaine injection: Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Normal Saline
The control group will receive an injection of 50mL of 0.9% sodium chloride solution.
normal saline: Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pain Injection
n=17 Participants
This group will be injected with a cocktail totaling 50mL (25mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Ropivacaine injection: Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Normal Saline
n=17 Participants
The control group will receive an injection of 50mL of 0.9% sodium chloride solution.
normal saline: Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.2 years
STANDARD_DEVIATION 2.4 • n=17 Participants
|
9.0 years
STANDARD_DEVIATION 2.9 • n=17 Participants
|
8.6 years
STANDARD_DEVIATION 2.6 • n=34 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=17 Participants
|
9 Participants
n=17 Participants
|
14 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=17 Participants
|
8 Participants
n=17 Participants
|
20 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
17 participants
n=17 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: During initial post-operative hospitalization (estimated 3-4 days)Average post-operative opioid consumption, measured in morphine equivalents per kilogram
Outcome measures
| Measure |
Normal Saline
n=17 Participants
The control group will receive an injection of 50mL of 0.9% sodium chloride solution.
normal saline: Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Pain Injection
n=17 Participants
This group will be injected with a cocktail totaling 50mL (25mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Ropivacaine injection: Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
|---|---|---|
|
Opioid Consumption
|
1.87 mEQ/kg
Standard Deviation 2.05
|
0.41 mEQ/kg
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 7 daysPost-operative hospital length of stay
Outcome measures
| Measure |
Normal Saline
n=17 Participants
The control group will receive an injection of 50mL of 0.9% sodium chloride solution.
normal saline: Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Pain Injection
n=17 Participants
This group will be injected with a cocktail totaling 50mL (25mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Ropivacaine injection: Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
|---|---|---|
|
Hospital Length of Stay
|
3.4 days
Standard Deviation 1.8
|
3.6 days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 7 daysPain score assessments will be completed in the post-anesthesia care unit, \& every 4 hours following surgical procedure. Scores will be collected by nursing staff on the inpatient ward who are blinded to treatment allocation and recorded in the electronic medical record. The type of pain score collection will vary based on patient age and level of intellectual disability. In verbal children, either the visual analog scale (VAS) or faces pain scale will be employed (scale 0-10; minimum 0, maximum 10). In non-verbal children, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be employed (scale 0-10; minimum 0, maximum 10). All 3 scales measure a patient's pain on a scale of zero (no pain) to ten (the worst pain). Lower values are considered better than higher values. These scores will be combined into an average score for the hospitalization. A higher average score indicates more pain (worse outcome), while a lower average score indicates less pain (better outcome).
Outcome measures
| Measure |
Normal Saline
n=17 Participants
The control group will receive an injection of 50mL of 0.9% sodium chloride solution.
normal saline: Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Pain Injection
n=17 Participants
This group will be injected with a cocktail totaling 50mL (25mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Ropivacaine injection: Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
|---|---|---|
|
Post-operative Pain Scores
|
2.4 scores on a scale
Standard Deviation 1.1
|
1.0 scores on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 3 weeksParent satisfaction will be based on a standardized, validated questionnaire taken by parents in person at the first post-operative clinic visit aimed to assess their satisfaction with their child's pain management peri-operatively. Questions pertaining to pain interference are answered with a score of 1-5, with 1 being the best outcome and 5 being the worst outcome. Questions pertaining to severity of side effects are answered with a score of 0-10, with 0 being the best outcome and 10 being the worst outcome. Overall satisfiction is rated 1-5, with one being the best outcome and 5 being the worst. Finally, estimated time spent in severe pain is a percentage (0-100), with 0 being the best outcome and 100 being the worst. The score for each question are added to obtain a total score. A higher total score indicates a worse level of satisfaction with perioperative pain management. The scale goes from minimum 5 to maximum 155, with a score of 5 being the best and 155 being the worst.
Outcome measures
| Measure |
Normal Saline
n=15 Participants
The control group will receive an injection of 50mL of 0.9% sodium chloride solution.
normal saline: Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
Pain Injection
n=12 Participants
This group will be injected with a cocktail totaling 50mL (25mL on each side) that will be composed of ropivicaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), ketorolac 30mg/mL (0.5mg/kg).
Ropivacaine injection: Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
|
|---|---|---|
|
Parent Satisfaction
|
47.3 score on a scale
Standard Deviation 22.0
|
48.9 score on a scale
Standard Deviation 30.6
|
Adverse Events
Pain Injection
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place