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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone Group | Experimental | 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. |
|
| Control Group | Active Comparator | Patient will receive normal saline placebo initially, then morphine prior to emergence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Perioperative IV methadone to be given |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Opioid Consumption (mg/kg) | Total amount of opioids consumed during the first 72 hours after surgery. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Weisman, MD | Children's Hospital and Health System Foundation, Wisconsin | Study Chair |
| Roger A Fons, MD | Children's Hospital and Health System Foundation, Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2066846 | Background | Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6. | |
| 20418538 | Background | Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Opioid Consumption (mg/kg) | Total amount of opioids consumed during the first 72 hours after surgery. | All participants allocated to study groups, and received the intervention. | Posted | Median | Inter-Quartile Range | mg/kg | 72 hours |
|
Three post-operative days.
Data represent the number of patients treated for each side effect, collapsed across post-operative days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keri R. Hainsworth, PhD | Medical College of Wisconsin | 414-266-6306 | khainswo@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | Nov 16, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D000077330 | Saline Solution |
| D005457 | Fluoridation |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| Normal Saline | Other | control arm |
|
|
| Morphine | Drug | Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump. |
|
|
| 20418301 | Background | Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2. |
| 22037641 | Background | Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |