Recruiting
Phase 3

Methadone & Oxycodone

Sponsor:

Senthil Sadhasivam

Code:

NCT06626503

Conditions

Idiopathic Scoliosis

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Methadone based ERAS

Non-methadone based group

Study Details

Brief summary:

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.

Conditions

Idiopathic Scoliosis

Study ID

NCT06626503

Start date

Oct 30, 2025

Status verified date

Feb, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 10 - < 18 years
2. American Society of Anesthesiologists (ASA) Physical Status 1 or 2
3. Undergoing PSF for idiopathic scoliosis
4. Participant or legal guardian can speak and read English or Spanish

Exclusion Criteria:

1. Pregnant patients
2. Methadone allergy
3. Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
4. Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)
5. Preoperative opioid use within 30 days before surgery
6. History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.
7. Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Methadone-Based ERAS Group

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.

active comparator: Non-Methadone-Based Group

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.

Interventions

Methadone based ERAS

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.

Non-methadone based group

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).

Primary outcome measure

  • Average postoperative pain scores [ Time Frame: Postoperative 48 hours ]
  • Total postoperative opioid use [ Time Frame: Postoperative 48 hours ]

Central Contacts and Locations

Central contacts

Senthilkumar Sadhasivam, MD, MPH, MBA, FASA

4126474484sadhasivams@upmc.edu

Dayana Alsamsam, BSPS, MSc

alsamsamd@upmc.edu

Locations

UPMC Children's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Senthilkumar Sadhasivam, MD, MPH

412-647-4484sadhasivams@upmc.edu

Amy Monroe, MPH

4126236283monroeal@upmc.edu

Principal Investigator:

Senthilkumar Sadhasivam, MD

More Information

Sponsor

Senthil Sadhasivam

Last update posted

May 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Senthil Sadhasivam on 2026-05-05.