NCT06626503 · Senthil Sadhasivam
Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
(PRECISE)
What this study is about
The conducted at multiple hospitals PRECISE Analgesia (forward-looking randomly assigned Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the effectiveness 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.
View original scientific 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
DRUG
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.
DRUG
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 measures
Average postoperative pain scores
Time frame: Postoperative 48 hours
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).
Total postoperative opioid use
Time frame: Postoperative 48 hours
Number of opioids used in hospital, will be reported as mean (SD).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Cincinnati, Ohio
- Pittsburgh, Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations