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| ID | Type | Description | Link |
|---|---|---|---|
| Active | Other Grant/Funding Number | Nationwide Children's Hospital Intramural Grant - 292913 |
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Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.
The current study would use a prospective, randomized trial investigating the efficacy of one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along with a third control group. The patients would be randomized to receive remifentanil plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of magnesium; or remifentanil alone. In addition, the two medications being studied might make it easier to determine the efficacy of neurophysiologic monitoring including somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA) required to elicit the response.
The purpose of this study would be to explore the effects of intraoperative methadone vs magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of desflurane, remifentanil, and the need for intraoperative supplemental agents to control blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Active Comparator | This arm will receive remifentanil alone as is the current practice. |
|
| Remifentanil plus methadone | Experimental | This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride. |
|
| Remifentanil plus magnesium | Experimental | This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone hydrochloride | Drug | This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Intra- and Post-operative Pain Relief | To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively. | Intra-operative and 24 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Scores | VAS pain score - 0 being no pain and 10 being worst pain. | Post-operatively to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P. Martin, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22978825 | Background | Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil | This arm will receive remifentanil alone as is the current practice. Remifentanil |
| FG001 | Remifentanil Plus Methadone | This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride. Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia |
| FG002 | Remifentanil Plus Magnesium | This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate. Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil | This arm will receive remifentanil alone as is the current practice. Remifentanil |
| BG001 | Remifentanil Plus Methadone | This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride. Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia |
| 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 | Intra- and Post-operative Pain Relief | To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively. | Posted | Mean | Standard Deviation | mg/kg | Intra-operative and 24 hours post-operatively |
|
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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 | Remifentanil | This arm will receive remifentanil alone as is the current practice. Remifentanil |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Martin, MD | Nationwide Children's Hospital | 6147224200 | David.Martin@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D008278 | Magnesium Sulfate |
| D008274 | Magnesium |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
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|
| Magnesium Sulfate | Drug | This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour). |
|
|
| Remifentanil | Drug |
|
| 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. |
| 16670112 | Background | Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. doi: 10.1093/bja/ael085. Epub 2006 May 2. |
| 12562408 | Background | Levaux Ch, Bonhomme V, Dewandre PY, Brichant JF, Hans P. Effect of intra-operative magnesium sulphate on pain relief and patient comfort after major lumbar orthopaedic surgery. Anaesthesia. 2003 Feb;58(2):131-5. doi: 10.1046/j.1365-2044.2003.02999.x. |
| 30078167 | Derived | Martin DP, Samora WP 3rd, Beebe AC, Klamar J, Gill L, Bhalla T, Veneziano G, Thung A, Tumin D, Barry N, Rice J, Tobias JD. Analgesic effects of methadone and magnesium following posterior spinal fusion for idiopathic scoliosis in adolescents: a randomized controlled trial. J Anesth. 2018 Oct;32(5):702-708. doi: 10.1007/s00540-018-2541-5. Epub 2018 Aug 4. |
| BG002 | Remifentanil Plus Magnesium | This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate. Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Remifentanil Plus Magnesium | This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate. Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour). |
|
|
| Secondary | Post-operative Pain Scores | VAS pain score - 0 being no pain and 10 being worst pain. | Posted | Mean | Standard Deviation | units on a scale | Post-operatively to 24 hours |
|
|
|
| 0 |
| 21 |
| 0 |
| 20 |
| EG001 | Remifentanil Plus Methadone | This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride. Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia | 0 | 22 | 0 | 22 |
| EG002 | Remifentanil Plus Magnesium | This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate. Magnesium Sulfate: This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour). | 0 | 20 | 0 | 21 |
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| D013431 |
| Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |