A Phase 3 interventional study of Methadone based ERAS and Non-methadone based group in Idiopathic Scoliosis, sponsored by Senthil Sadhasivam. Recruiting at 4 sites in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Senthil Sadhasivam · Phase 3, Interventional, and Treatment
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Among 153 studies in Scoliosis with a site in United States — 42 open to participants now, 52 under way, 2 of them phase 3. Scoliosis · United States.
Among the 153 studies in Scoliosis with a site in United States, this one is the 2nd largest by planned enrollment of the 91 interventional ones that give a count, is one of 9 that started in 2025, is one of 3 in phase 3, reaches primary completion later than 42 of the 51 other live ones, and was the 140th registered.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
Browse Scoliosis studies →42 of the 153 studies in Scoliosis with a site in United States are open now. Recruiting first, the newest first:
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 14–26
Thinks Works, PBC · Sites in United States
Ages 9–16
Columbia University · Sites in United States
Ages 10–19
Children's Hospital Los Angeles · Sites in United States
Ages 8–18
Baylor College of Medicine · Sites in United States
Ages 8–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 117 Scoliosis studies recruiting now, 23 (20%) set no upper age limit and 88 (75%) stop at 75 or younger; 98 take children under 18; 14 take healthy volunteers.
This study: 10 Years to 18 Years · all sexes · no healthy volunteers.
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153 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 6 · Phase 4 15
First in 1998; this study’s year is marked. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Median enrollment 58 across the 91 interventional studies, 100 across the 62 observational. Of the 84 that completed or were terminated, 35 (42%) have results posted.
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24 of 153 have an industry lead sponsor. The 10 most frequent:
Senthil Sadhasivam is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Senthil Sadhasivam has 1 study filed under Scoliosis — fewer than ten, so there is no comparison to draw.
20 of the studies in Scoliosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07217873Phase 3Columbia UniversityIntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study | 2027-08-31 |
| NCT00738439International Spine Study Group FoundationProspective, Multi-Center Adult Spinal Deformity Outcomes Database Registry | 2026-12 |
| NCT06910228Joseph D. TobiasChanges in Cerebral Oxygenation Related to Intraoperative Position Changes | 2026-12 |
| NCT06365892University of California, San FranciscoOpen-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis | 2026-12 |
| NCT03017755Mayo ClinicScoliosis Survey to Development Treatment Decision Tool | 2026-12-01 |
Add all 20 to your calendar (.ics) → With an account.
Among the 153 studies in Scoliosis with a site in United States, from their registry updates:
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The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.
SPECIFIC AIMS. The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing, and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.
The long-term goal is to proactively improve the safety and efficacy of surgical pain control while reducing opioid AEs and the opioid epidemic burden in all children undergoing inpatient surgeries. The central hypothesis is that a standardized, multidose, methadone-based ERAS protocol will reduce acute surgical pain, overall opioid use, RD, PONV, and CPSP compared with standard-of-care short-acting opioid-based analgesia in children undergoing PSF (Aim 1). Investigators will use PK and genetic variations along with clinical factors to develop optimal intra- and post-operative methadone dosing in children to enable precision analgesia in the future (Aim 2). Finally, Investigators will identify patient profiles with genetic, epigenetic, PK, clinical, and psychological factors to predict benefit from assigned analgesia for optimal clinical outcomes (Aim 3). The expert multidisciplinary and multicenter team will enroll a total of 1000 children to conduct a randomized clinical trial for PSF (500 children 10-\<18 yrs from 4 clinical sites). In this study, specifically, Investigators will:
Aim 1. Conduct a randomized clinical trial in PSF to compare acute pain relief, opioid-sparing efficacy, and safety of standardized perioperative multidose methadone-based ERAS vs. standard-of-care non-methadone-based analgesia. Acute surgical pain, opioid needs (morphine equivalents), RD, PONV, and CPSP will be lower in methadone-based analgesia compared to short-acting opioid-based analgesia.
Aim 2. Develop precision methadone dosing based on age, CYP2B6 and ORM1 variants, and AAG. Age, CYP2B6 and ORM1 variants, AAG levels, and will explain methadone's PK variability and dose adjustments that correlate with optimal clinical outcomes among 500 children receiving methadone.
Aim 3. Identify patient profiles that predict benefits from the assigned analgesia protocol to optimize clinical outcomes. Personalized risk prediction models will be developed and validated including genetic variants (i.e., CYP2B6, CYP2D6, ABCB1, OPRM1, and FAAH), and psychological and clinical factors to predict benefit with the assigned treatments (methadone or non-methadone) for pre-specified clinical endpoints (i.e., lower acute surgical pain, RD, PONV, OD, and CPSP) in PSF.
Overall Impact: Develop actionable evidence for the efficacy of standardized, multidose, methadone-based ERAS protocols and will harness genetic, clinical, and psychological factors contributing to variability in methadone and oxycodone PK, acute surgical pain, transition to CPSP, opioid-induced PONV, RD, and dependence to develop personalized analgesia strategy and dosing for children undergoing PSF. Implementation of evidence-based standardized methadone-based ERAS pain management and individualized risk prediction will maximize acute surgical pain relief while minimizing opioid use and AEs in millions of children.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The methadone-based standardized analgesia intervention arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
Drug: Methadone based ERAS
The comparator standard-of-care non-methadone-based analgesia arm will include standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.
Drug: Non-methadone based group
Methadone intervention includes intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
Also known as: Methadone Based
Non-methadone intervention includes standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. Postoperative pain medication is recommended when reported pain level is considered moderate or higher (≥4 on NRS and FLACC).
Also known as: Non-methadone
Average postoperative pain scores
Average postoperative pain scores at 48-hours timepoint using 0-10, Numerical Rating Scale (NRS), in which 0=no pain at all and 10=worst pain imaginable. Outcome will be reported based on area under the curve (AUC) as mean(SD).
Time frame: Postoperative 48 hours
Total postoperative opioid use
Number of opioids used in hospital, will be reported as mean (SD).
Time frame: Postoperative 48 hours
Incidence of inpatient respiratory depression (RD)
RD is defined as persistent oxygen desaturation (SpO2) \<90% on room air or respiratory rate \<8 breaths per minute requiring oxygen in the absence of airway obstruction. Outcome will be reported as n(%).
Time frame: Postoperative 120-hours
Incidence of Postoperative Nausea and Vomiting (PONV)
PONV will be assessed by self-report, EMR, and medication use. Outcome will be reported as n(%).
Time frame: Postoperative 120-hours
Incidence of Inpatient Sedation
Sedation will be assessed using the Ramsay Sedation Scale (RSS) and validated sedation scales extracted from the EMR. Outcome will be reported as n(%).
Time frame: Postoperative 120-hours
QTc Prolongation
QTc prolongation is defined as \>460 msec based on 12-lead or 15-lead EKG. Outcome will be reported as n(%).
Time frame: Postoperative 48-hours
Length of Hospital Stay (LOS)
LOS will be measured in days until hospital discharge. Outcome will be reported as mean (SD).
Time frame: Up to 30 days
Persistent opioid use
Based on Prescription Drug Monitoring Program (PDMP) and self-report data. Outcome will be reported as n(%).
Time frame: 1-week, 1-month, and 3-months post-surgery
Presence of Chronic Postsurgical Pain (CPSP) at 3-months
CPSP incidence will be defined using NRS pain \>3/10 and functional limitations based on Functional Disability Index (FDI). NRS Pain scale is 0=no pain at all and 10=worst pain imaginable. Outcome will be reported as n(%).
Time frame: 3-months post-surgery
Presence of Opioid Dependence (OD) at 3-months
OD will be assessed using PROMIS and Prescription Pain Medication Misuse (PPMM) scales. Outcome will be reported as n(%).
Time frame: 3-months post-surgery
Plan to share: Yes — Identifiable data and specimens will be shared with the sponsor of the study. The investigators and study team will comply with all the NIH's Public Access and Data Sharing requirements including Release of Publications and Sharing of Underlying Primary Data. Release of Publications: The investigators will publish their results in open access journals for broad and free availability immediately without any embargo period. Electronic copies of publications will be deposited within four weeks of acceptance by a journal in PubMed Central with proper metadata to be made discoverable and accessible upon publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Time frame is within 5-years of study completion.
Access criteria: Online collaborative tools to facilitate data sharing such as SharePoint or Xythos
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jan 2029, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Senthil Sadhasivam