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Opioid

Methadone-Based Analgesia for Scoliosis Surgery

Phase 2

Waitlist Available

Led By Senthilkumar Sadhasivam, MD

Research Sponsored by Senthil Sadhasivam

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 10-<18 for PSF trial

Undergoing PSF for idiopathic scoliosis

Must not have

Neurological disease

Pregnant patients <18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1-week post-operative, week 1 post-discharge, month 1, and month 3

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the use of a methadone-based recovery protocol to the current standard of care in children undergoing spinal surgery. Participants will be randomly assigned to one of the two groups, similar

Who is the study for?

This trial is for children undergoing elective spine fusion surgery to correct scoliosis, including idiopathic scoliosis. Specific eligibility criteria are not provided, but typically include a certain age range and health status.

What is being tested?

The study compares two post-surgery recovery protocols: one using methadone (a strong painkiller) and another with standard care that doesn't use methadone. Children will be randomly placed in either group by chance.

What are the potential side effects?

While specific side effects aren't listed, methadone can generally cause drowsiness, nausea, constipation, breathing problems, and potential dependency issues.

Eligibility Criteria

Inclusion Criteria

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

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I am between 10 and 17 years old.

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I am having surgery for scoliosis not caused by other conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition.

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I am pregnant and under 18.

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I have been diagnosed with severe sleep apnea.

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I have a serious health condition that limits my activity but is not incapacitating.

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I have been using opioids before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1-week post-operative, week 1 post-discharge, month 1, and month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1-week post-operative, week 1 post-discharge, month 1, and month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1-week post-operative, week 1 post-discharge, month 1, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average postoperative pain scores

Total postoperative opioid use

Secondary study objectives

Generalized Anxiety Disorder-2 (GAD-2)

Length of Stay (LOS)

Opioid Dependence

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Methadone-Based ERAS GroupExperimental Treatment1 Intervention

Children randomized to the methadone arm will receive standardized perioperative care and analgesia, including intraoperative intravenous methadone (0.1 mg/kg up to a maximum of 5 mg before incision and 0.05 mg at the end of surgery) and postoperatively, up to 4 oral doses of methadone every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.

Group II: SOC Non-Methadone-Based GroupActive Control1 Intervention

Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.

0 / 7Eligibility criteria met