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Completed

NCT Number: NCT01795495

Methadone vs Magnesium in Spinal Fusion

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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Key information

Conditions

Idiopathic Scoliosis Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Methadone

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).

Other names: Magnesium

Remifentanil

Drug

Primary outcomes

  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 outcomes

  1. Post-operative Pain Scores

    Time frame: Post-operatively to 24 hours

    VAS pain score - 0 being no pain and 10 being worst pain.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2013
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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