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Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).
Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methadone HCl 0.3 mg/kg | Experimental | 0.3mg/kg IV methadone HCl |
|
| methadone HCl 0.4 mg/kg | Experimental | 0.4mg/kg IV methadon HCl |
|
| control group | Active Comparator | control no methadone, standard of care opioids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3mg/kg IV methadone HCl | Drug | Group I will receive 0.3mg/kg IV methadone HCl |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption (Morphine Equivalent) | Measure of overall morphine consumption | 6 days |
| Pain Scores | Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated . | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of R and S Methadone | Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose. | 96 hours |
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Inclusion Criteria.
Exclusion Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Anshuman Sharma, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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53 signed consents however, 2 participants withdrew prior to randomization:
1 per family request
1 unable to complete
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone HCl 0.3 mg/kg | 0.3mg/kg IV methadone HCl 0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl |
| FG001 | Methadone HCl 0.4 mg/kg | 0.4mg/kg IV methadon HCl 0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl. |
| FG002 | Control Group | control no methadone, standard of care opioids. control no methadone: The control group will not receive methadone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone 0.3 mg/kg | 0.3mg/kg IV methadone 0.3mg/kg IV methadone : Group I will receive 0.3mg/kg IV methadone |
| BG001 | Methadone 0.4 mg/kg | 0.4mg/kg IV methadone 0.4mg/kg IV methadone: Group II will receive 0.4mg/kg IV methadone . |
| 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 | Total Opioid Consumption (Morphine Equivalent) | Measure of overall morphine consumption | Posted | Mean | Standard Deviation | mg/kg | 6 days |
|
Up to 6 days post-preoperative.
Patients were assessed each day, in the morning, for events.
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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 HCl 0.3 mg/kg | 0.3mg/kg IV methadone HCl 0.3mg/kg IV methadone HCl: Group I will receive 0.3mg/kg IV methadone HCl |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excessive sedation | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anshuman Sharma | Washington University School of Medicine | 314-457-3147 | sharma.a@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2017 | Sep 9, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2014 | Sep 9, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000578 | Amidines |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
| D007659 | Ketones |
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| 0.4mg/kg IV methadon HCl | Drug | Group II will receive 0.4mg/kg IV methadone HCl. |
|
|
| control no methadone | Other | The control group will not receive methadone. |
|
| BG002 | Control Group | control no methadone, standard of care opioids. control no methadone: The control group will not receive methadone. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiologists (ASA) Physical Satus | The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning), it can be helpful in predicting perioperative risks. | Count of Participants | Participants |
|
| Pre-operative pain score | Numeric Pain Score was used to measure patient reported pain. The scale, previously validated, measures pain from 0 to 10, zero being no pain and 10 being the highest imaginable pain | Mean | Standard Deviation | units on a scale |
|
| Expected Post-operative Pain Score | Numeric Pain Score was used to measure patient reported pain. The scale, previously validated, measures pain from 0 to 10, zero being no pain and 10 being the highest imaginable pain | Mean | Standard Deviation | 0-10 units on a Visual Analog scale |
|
| BMI | Mean | Standard Deviation | kg/m^2 scale |
|
control no methadone, standard of care opioids.
control no methadone: The control group will not receive methadone.
|
|
|
| Primary | Pain Scores | Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated . | Posted | Mean | Standard Deviation | score on a scale | 6 days |
|
|
|
|
| Secondary | Cmax of R and S Methadone | Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose. | Methadone clearance was only measured in the two groups that received methadone | Posted | Mean | Standard Deviation | ng/ml | 96 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Methadone HCl 0.4 mg/kg | 0.4mg/kg IV methadon HCl 0.4mg/kg IV methadon HCl: Group II will receive 0.4mg/kg IV methadone HCl. | 0 | 14 | 0 | 14 | 6 | 14 |
| EG002 | Control Group | control no methadone, standard of care opioids. control no methadone: The control group will not receive methadone. | 0 | 16 | 0 | 16 | 8 | 16 |
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory Rate <8/min or Saturations <90% for more than 30 sec |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment | Delayed return of bowel sounds |
|
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