Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)
Senthil Sadhasivam
500 participants
Oct 30, 2025
INTERVENTIONAL
Conditions
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 dosing1,2 and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.
Eligibility
Inclusion Criteria4
- Participants aged 10-\<18yrs for PSF trial
- ASA physical status 1\&2
- Undergoing PSF for idiopathic scoliosis
- Participant or legal guardian can speak and read English or Spanish
Exclusion Criteria7
- 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 (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness)
- Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator.
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Interventions
Methadone intervention includes intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.05 mg/kg up to a maximum of 2.5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral doses of methadone every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06626503