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RECRUITING Phase 3 ClinicalTrials.gov

Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

Sponsor: Senthil Sadhasivam • ClinicalTrials.gov ID: NCT06626503

Registry updated: 2026-10-07
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Description

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.

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.
  • 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).

Eligibility criteria

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

Conditions

Idiopathic Scoliosis

Locations

  • Riley Children's Hospital — Indianapolis, Indiana, United States
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
  • UPMC Children's Hospital — Pittsburgh, Pennsylvania, United States
  • Texas Children's Hospital — Houston, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record