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Methadone vs Magnesium in Spinal Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01795495
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
David P. Martin, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Idiopathic Scoliosis Drug: Methadone hydrochloride Drug: Magnesium Sulfate Drug: Remifentanil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium
Study Start Date : September 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Remifentanil
This arm will receive remifentanil alone as is the current practice.
Drug: Remifentanil
Experimental: Remifentanil plus methadone
This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.
Drug: 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
Other Name: Methadone

Experimental: Remifentanil plus magnesium
This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.
Drug: 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).
Other Name: Magnesium

Primary Outcome Measures :
  1. Intra- and Post-operative Pain Relief [ Time Frame: Intra-operative and 24 hours post-operatively ]
    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 :
  1. Post-operative Pain Scores [ Time Frame: Post-operatively to 24 hours ]
    VAS pain score - 0 being no pain and 10 being worst pain.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01795495

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
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Principal Investigator: David P. Martin, MD Nationwide Children's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David P. Martin, Clinical Assistant Professor, Nationwide Children's Hospital Identifier: NCT01795495    
Other Study ID Numbers: IRB13-0036
Active ( Other Grant/Funding Number: Nationwide Children's Hospital Intramural Grant - 292913 )
First Posted: February 20, 2013    Key Record Dates
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018
Last Verified: February 2018
Keywords provided by David P. Martin, Nationwide Children's Hospital:
Spinal Fusion
Back Surgery
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Magnesium Sulfate
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Antitussive Agents
Respiratory System Agents