Idiopathic Scoliosis, Post-operative Pain
Conditions
Brief summary
This study hypothesizes that the addition of a low-dose ketamine infusion to usual post-operative pain management will improve pain control as evidenced by an improvement in post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.
Detailed description
After consenting, patients will be randomized by the pharmacy. In the operating room patients will receive ketamine/placebo 0.5mg/kg bolus prior to the surgical incision, followed by ketamine/placebo 0.2mg/kg continuous infusion up to 48hours. All the patients will also receive 15mg/k IV acetaminophen at the end of the surgery, followed by every 6hr for 48hrs. Rest of the pain regimen will be the usual post-operative pain management for spinal fusion for idiopathic scoliosis, which includes morphine PCA, IV ketorolac from POD 1, and flexaril from POD 1. All the patients and parents will fill out a survey at 0hr, 24hr and 48hr grading their level of satisfaction with the post-operative pain.
Interventions
DRUGKetamine
OTHERPlacebo
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ASA I, II, III * Presenting for spinal fusion for idiopathic scoliosis * English-speaking and able to give assent
Exclusion criteria
* Any contraindication to ketamine * Previous spinal surgery * Opioid dependence * Chronic pain condition * Significant developmental delay * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Through study completion, 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Through study completion 48 hours | 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. |
| Opioid Use | Through study completion, 48 hours | Total Morphine consumption will be collected from Patient Controlled Analgesia (PCA) morphine pump. The secondary outcome measure was total morphine consumption difference in 48hrs. |
| Length of Stay | Through study completion, 48 hours | Length of hospital stay from surgery to discharge |
Countries
United States
Participant flow
Recruitment details
50 participants started but only 49 participants received treatment. Total enrollment would be 49. Recruitment total was 50.
Pre-assignment details
randomized
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| Placebo A placebo (saline) will be given in place of ketamine
Placebo | 25 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | drug not administered, due dispensing issue | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Treatment Group |
|---|---|---|---|
| Age, Customized mean age | 14.7 years STANDARD_DEVIATION 2.19 | 14.05 years STANDARD_DEVIATION 1.945 | 13.4 years STANDARD_DEVIATION 1.72 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 Participants | 49 Participants | 24 Participants |
| Sex: Female, Male Female | 17 Participants | 39 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 3 / 24 | 9 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
Patient Satisfaction
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.
Time frame: Through study completion, 48 hours
Population: pediatric patient under 18yrs of age, total Femle 39 and total male 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Patient Satisfaction | parent pain satisfaction score | 3.31 score on a scale | Standard Deviation 0.805 |
| Treatment Group | Patient Satisfaction | patient pain satisfaction scores | 2.75 score on a scale | Standard Deviation 0.808 |
| Placebo | Patient Satisfaction | parent pain satisfaction score | 3.13 score on a scale | Standard Deviation 0.705 |
| Placebo | Patient Satisfaction | patient pain satisfaction scores | 2.92 score on a scale | Standard Deviation 0.712 |
Secondary
Length of Stay
Length of hospital stay from surgery to discharge
Time frame: Through study completion, 48 hours
Population: pediatric patient under age of 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Length of Stay | 5.46 hours | Standard Deviation 0.721 |
| Placebo | Length of Stay | 5.52 hours | Standard Deviation 0.653 |
Secondary
Opioid Use
Total Morphine consumption will be collected from Patient Controlled Analgesia (PCA) morphine pump. The secondary outcome measure was total morphine consumption difference in 48hrs.
Time frame: Through study completion, 48 hours
Population: pediatric patient under the age of 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Opioid Use | 0.577 mg | Standard Deviation 0.374 |
| Placebo | Opioid Use | 0.83 mg | Standard Deviation 0.466 |
Secondary
Pain Score
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.
Time frame: Through study completion 48 hours
Population: pediatric patient under 18yrs of age
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Pain Score | 3.17 score on a scale | Standard Deviation 1.71 |
| Placebo | Pain Score | 3.9 score on a scale | Standard Deviation 1.81 |