RecruitingPhase 3

Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

United States500 participantsStarted 2025-10-30

Plain-language 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.

Who can participate

Age range10 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Average postoperative pain scores

Timeframe: Postoperative 48 hours

Total postoperative opioid use

Timeframe: Postoperative 48 hours

Trial details

NCT IDNCT06626503

SponsorSenthil Sadhasivam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-31

Contact for this trial

Senthilkumar Sadhasivam, MD, MPH, MBA, FASA

4126474484 sadhasivams@upmc.edu

View on ClinicalTrials.gov More Idiopathic Scoliosis trials