Trial Outcomes & Findings for Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis (NCT NCT02651324)
NCT ID: NCT02651324
Last Updated: 2025-02-20
Results Overview
All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management. Patient Satisfaction Score from a scale of 1 - 4 was used - 1. Unsatisfied 2. Moderately satisfied 3 - Generally satisfied 4 - Very satisfied No other subscales were included.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Through study completion, 48 hours
Results posted on
2025-02-20
Participant Flow
50 participants started but only 49 participants received treatment. Total enrollment would be 49. Recruitment total was 50.
randomized
Participant milestones
| Measure |
Treatment Group
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Group
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Overall Study
drug not administered, due dispensing issue
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=24 Participants
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
n=25 Participants
A placebo (saline) will be given in place of ketamine
Placebo
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
mean age
|
13.4 years
STANDARD_DEVIATION 1.72 • n=24 Participants
|
14.7 years
STANDARD_DEVIATION 2.19 • n=25 Participants
|
14.05 years
STANDARD_DEVIATION 1.945 • n=49 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=24 Participants
|
17 Participants
n=25 Participants
|
39 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=24 Participants
|
8 Participants
n=25 Participants
|
10 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
25 Participants
n=25 Participants
|
49 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Through study completion, 48 hoursPopulation: pediatric patient under 18yrs of age, total Femle 39 and total male 10
All the patients and parent will fill out a survey grading their level of satisfaction with their post-operative pain management. Patient Satisfaction Score from a scale of 1 - 4 was used - 1. Unsatisfied 2. Moderately satisfied 3 - Generally satisfied 4 - Very satisfied No other subscales were included.
Outcome measures
| Measure |
Treatment Group
n=24 Participants
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
n=20 Participants
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Patient Satisfaction
patient pain satisfaction scores
|
2.75 score on a scale
Standard Deviation 0.808
|
2.92 score on a scale
Standard Deviation 0.712
|
|
Patient Satisfaction
parent pain satisfaction score
|
3.31 score on a scale
Standard Deviation 0.805
|
3.13 score on a scale
Standard Deviation 0.705
|
SECONDARY outcome
Timeframe: Through study completion 48 hoursPopulation: pediatric patient under 18yrs of age
Pain scores will be collected from the nursing sheet. Pain score was measured using "self-rating numeric scale" a scale from 1 to 10, where 1 is minimum pain and 10 is maximum pain. No other subscales were done.
Outcome measures
| Measure |
Treatment Group
n=24 Participants
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
n=24 Participants
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Pain Score
|
3.17 score on a scale
Standard Deviation 1.71
|
3.9 score on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Through study completion, 48 hoursPopulation: pediatric patient under the age of 18
Total Morphine consumption will be collected from Patient Controlled Analgesia (PCA) morphine pump. The secondary outcome measure was total morphine consumption difference in 48hrs.
Outcome measures
| Measure |
Treatment Group
n=24 Participants
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
n=25 Participants
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Opioid Use
|
0.577 mg
Standard Deviation 0.374
|
0.83 mg
Standard Deviation 0.466
|
SECONDARY outcome
Timeframe: Through study completion, 48 hoursPopulation: pediatric patient under age of 18
Length of hospital stay from surgery to discharge
Outcome measures
| Measure |
Treatment Group
n=24 Participants
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
n=25 Participants
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Length of Stay
|
5.46 hours
Standard Deviation 0.721
|
5.52 hours
Standard Deviation 0.653
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=24 participants at risk
A ketamine bolus of 0.5mg/kg will be given and then the ketamine infusion of 0.2 mg/kg/hr will be initiated prior to incision. Intra-operative opioids will be at the discretion of the attending anesthesiologist. Postoperative management will include continuation of the study drug as well as a standardized morphine patient-controlled analgesia (PCA) and acetaminophen 15 mg/kg IV every 6 hours. On postoperative day 1, patients are started on ketorolac 0.5 mg/kg up to 15 mg IV q8h. On postoperative day 2 they are transitioned to ibuprofen 10 mg/kg up to 600 mg. The ketamine infusion will continue for 48 hours post operatively at which point the PCA is discontinued and patients are transitioned to oral pain medications (Roxicet or Lortab and Flexeril) as per the current protocol.
Ketamine
|
Placebo
n=25 participants at risk
A placebo (saline) will be given in place of ketamine
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
GI symptoms
|
12.5%
3/24 • Number of events 24 • we monitored the patients for adverse events for 48hrs after the surgery.
|
12.0%
3/25 • Number of events 25 • we monitored the patients for adverse events for 48hrs after the surgery.
|
|
Cardiac disorders
cardiac
|
4.2%
1/24 • Number of events 24 • we monitored the patients for adverse events for 48hrs after the surgery.
|
0.00%
0/25 • we monitored the patients for adverse events for 48hrs after the surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place