A Phase 3 interventional study of Methadone and Normal Saline in Scoliosis and Pain, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Medical College of Wisconsin · Phase 3, Interventional, and Treatment
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 58 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Methadone · Drug: Morphine
Patient will receive normal saline placebo initially, then morphine prior to emergence.
Other: Normal Saline · Drug: Morphine
Perioperative IV methadone to be given
Also known as: generic methadone
control arm
Also known as: salt water
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Also known as: Duramorph
Post-operative Opioid Consumption (mg/kg)
Total amount of opioids consumed during the first 72 hours after surgery.
Time frame: 72 hours
| Milestone | Methadone Group | Control Group |
|---|---|---|
| Started | 30 | 28 |
| Completed | 25 | 22 |
| Not completed | 5 | 6 |
Total amount of opioids consumed during the first 72 hours after surgery.
| mg/kg | Methadone Group | Control Group |
|---|---|---|
| Post-operative Opioid Consumption (mg/kg) | 0.267 (0.119 to 0.451) | 0.340 (0.168 to 0.607) |
Collected over Three post-operative days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methadone Group | 0/25 (0%) | 0/25 (0%) | 1/25 (4%) |
| Control Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Event | Methadone Group | Control Group |
|---|---|---|
| Respiratory depressionRespiratory, thoracic and mediastinal disorders | 1/25 | 0/22 |
| Age, Continuous(years) | Methadone Group | Control Group | Total |
|---|---|---|---|
| Mean | 15.0 ± 1.8 | 14.6 ± 2.3 | 14.81 ± 2.06 |
| Sex: Female, Male(Participants) | Methadone Group | Control Group | Total |
|---|---|---|---|
| Female | 21 | 17 | 38 |
| Male | 4 | 5 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Methadone Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 24 | 20 | 44 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Methadone Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 20 | 18 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Methadone Group | Control Group | Total |
|---|---|---|---|
| United States | 25 | 22 | 47 |
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Medical College of Wisconsin