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Narcotic

Methadone for Laminectomy

Phase 4
Waitlist Available
Led By Roya Yumul, M.D., PhD.
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial is testing whether ketamine and methadone can reduce pain after lumbar surgery.

Eligible Conditions
  • Laminectomy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Consumption Obtained From the Recorded Data
Postoperative Pain
Secondary outcome measures
Nausea and Vomiting
Number of Participants With Constipation at Follow up

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine + methadoneExperimental Treatment2 Interventions
Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Group II: KetamineActive Control2 Interventions
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
Group III: MethadoneActive Control2 Interventions
Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methadone
2005
Completed Phase 4
~2930
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,886 Total Patients Enrolled
2 Trials studying Laminectomy
173 Patients Enrolled for Laminectomy
Roya Yumul, M.D., PhD.Principal InvestigatorCedars-Sinai Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants below the age of 65 permissible to partake in this inquiry?

"As per the trial requirements, participants must be aged 18-80 to qualify for inclusion."

Answered by AI

What primary ailments is Methadone typically administered to treat?

"Methadone has multiple applications, including but not limited to treating opioid addiction and providing pain relief or general anesthesia."

Answered by AI

What is the current size of the cohort involved in this investigation?

"All recruitment for this clinical trial has been concluded. Initially launched in February 1, 2013 and edited on the 9th of the same month this year, it is no longer accepting participants. Alternately, there are currently 484 trials actively admitting candidates undergoing laminectomy and 113 studies that use Methadone recruiting new patients."

Answered by AI

Has Methadone been granted official sanctioning by the FDA?

"As this phase 4 clinical trial suggests, Methadone is approved for use and thus earned a safety rating of 3."

Answered by AI

Are individuals currently being accepted to participate in this experiment?

"According to records on clinicaltrials.gov, this trial has not been actively seeking out participants since February 9th 2022; the original post date was 2/1/13. Nonetheless, there are still 597 other trials that are currently recruiting patients."

Answered by AI

Is there an opportunity to participate in this research?

"This study is accepting a cohort of 114 adult volunteers, aged between 18 and 80, that require laminectomy. To be eligible for admission to the trial, participants must meet these requirements: • Be over 18 years old but under 80• Possessing either gender identity• Requiring elective lumbar laminectomy"

Answered by AI

Is this an unprecedented exploration of the subject?

"As of now, 113 Methadone studies are running in 83 cities and 22 countries. The initial trial for this drug took place in 2011; sponsored by Laboratoires Bouchara-Recordati, it had 146 participants and finished its Phase 3 trials successfully. Since then, 531 separate experiments have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
Roya Yumul, M.D.,PhD. 2013. "The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02252432.
~1 spots leftby Apr 2025
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