Pain, Scoliosis
Conditions
Keywords
Methadone, Gabapentin, Postoperative Pain, Posterior Spinal Fusion, Pediatric
Brief summary
Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions. Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.
Detailed description
This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.
Interventions
DRUGMethadone
Perioperative IV methadone to be given
OTHERNormal Saline
control arm
DRUGMorphine
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 10-18 years * Idiopathic scoliosis * Fusion levels planned for 10 or greater * English speaking * American Society of Anesthesiology (ASA) class 1 - 3
Exclusion criteria
* Current narcotic use / History of substance use disorder * Morphine, hydromorphone or methadone allergies * Pregnancy * Seizure disorders * Bleeding disorders * Neuromuscular scoliosis * History of renal or hepatic disease * Long QT syndrome * Obstructive sleep apnea * Body mass index \> 40 * Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen) * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Consumption (mg/kg) | 72 hours | Total amount of opioids consumed during the first 72 hours after surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methadone Group Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.
Methadone: Perioperative IV methadone to be given
Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump. | 25 |
| Control Group Patient will receive normal saline placebo initially, then morphine prior to emergence.
Normal Saline: control arm
Morphine: Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump. | 22 |
| Total | 47 |
Baseline characteristics
| Characteristic | Methadone Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 15.0 years STANDARD_DEVIATION 1.8 | 14.81 years STANDARD_DEVIATION 2.06 | 14.6 years STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 44 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 38 Participants | 18 Participants |
| Region of Enrollment United States | 25 participants | 47 participants | 22 participants |
| Sex: Female, Male Female | 21 Participants | 38 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 22 |
| other Total, other adverse events | 1 / 25 | 0 / 22 |
| serious Total, serious adverse events | 0 / 25 | 0 / 22 |
Outcome results
Primary
Post-operative Opioid Consumption (mg/kg)
Total amount of opioids consumed during the first 72 hours after surgery.
Time frame: 72 hours
Population: All participants allocated to study groups, and received the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Methadone Group | Post-operative Opioid Consumption (mg/kg) | 0.267 mg/kg |
| Control Group | Post-operative Opioid Consumption (mg/kg) | 0.340 mg/kg |
p-value: <0.05Mixed Models Analysis