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Methadone vs Magnesium in Spinal Fusion

Primary Purpose

Idiopathic Scoliosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methadone hydrochloride
Magnesium Sulfate
Remifentanil
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Idiopathic Scoliosis focused on measuring Spinal Fusion, Scoliosis, Methadone, Magnesium, Adolescents, Back Surgery

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis
  • American Society of Anesthesiologist (ASA) physical status I or II
  • Parents/Guardian willing and able to authorize informed consent
  • Patients willing and able to authorize assent

Exclusion Criteria:

  • Patients presenting with neuromuscular scoliosis
  • Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment
  • Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Remifentanil

Remifentanil plus methadone

Remifentanil plus magnesium

Arm Description

This arm will receive remifentanil alone as is the current practice.

This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.

This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-operative Pain Scores
VAS pain score - 0 being no pain and 10 being worst pain.

Full Information

First Posted
February 18, 2013
Last Updated
February 6, 2018
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01795495
Brief Title
Methadone vs Magnesium in Spinal Fusion
Official Title
Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
Spinal Fusion, Scoliosis, Methadone, Magnesium, Adolescents, Back Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
This arm will receive remifentanil alone as is the current practice.
Arm Title
Remifentanil plus methadone
Arm Type
Experimental
Arm Description
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Arm Title
Remifentanil plus magnesium
Arm Type
Experimental
Arm Description
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Intervention Type
Drug
Intervention Name(s)
Methadone hydrochloride
Other Intervention Name(s)
Methadone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Magnesium
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Primary Outcome Measure Information:
Title
Intra- and Post-operative Pain Relief
Description
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.
Time Frame
Intra-operative and 24 hours post-operatively
Secondary Outcome Measure Information:
Title
Post-operative Pain Scores
Description
VAS pain score - 0 being no pain and 10 being worst pain.
Time Frame
Post-operatively to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis American Society of Anesthesiologist (ASA) physical status I or II Parents/Guardian willing and able to authorize informed consent Patients willing and able to authorize assent Exclusion Criteria: Patients presenting with neuromuscular scoliosis Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P. Martin, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22978825
Citation
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.
Results Reference
background
PubMed Identifier
22037641
Citation
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.
Results Reference
background
PubMed Identifier
20418538
Citation
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.
Results Reference
background
PubMed Identifier
16670112
Citation
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.
Results Reference
background
PubMed Identifier
12562408
Citation
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.
Results Reference
background
PubMed Identifier
30078167
Citation
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.
Results Reference
derived

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Methadone vs Magnesium in Spinal Fusion

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