Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

NCT06626503 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY240400871U01HD116257-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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).

  Postoperative 48 hours

• Total postoperative opioid use

  Number of opioids used in hospital, will be reported as mean (SD).

  Postoperative 48 hours

Secondary Outcomes (8)

• Incidence of inpatient respiratory depression (RD)

  Postoperative 120-hours

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Postoperative 120-hours

• Incidence of Inpatient Sedation

  Postoperative 120-hours

• QTc Prolongation

  Postoperative 48-hours

• Length of Hospital Stay (LOS)

  Up to 30 days

Study Arms (2)

Methadone-Based ERAS Group

EXPERIMENTAL

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

Non-Methadone-Based Group

ACTIVE COMPARATOR

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

Interventions

Methadone based ERAS DRUG

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

Methadone-Based ERAS Group

Non-methadone based group DRUG

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

Non-Methadone-Based Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant patients
• Methadone allergy
• Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)
• 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)
• Preoperative opioid use within 30 days before surgery
• History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.
• Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator

Sponsors & Collaborators

• Senthil Sadhasivam: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Study Officials

• Senthilkumar Sadhasivam, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senthilkumar Sadhasivam, MD, MPH, MBA, FASA

CONTACT

4126474484; sadhasivams@upmc.edu

Dayana Alsamsam, BSPS, MSc

CONTACT

alsamsamd@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: October 4, 2024
• Study Start: October 30, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

US (2)