Actively Recruiting
Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
Led by Senthil Sadhasivam · Updated on 2026-05-05
500
Participants Needed
2
Research Sites
200 weeks
Total Duration
On this page
Sponsors
S
Senthil Sadhasivam
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Analgesia for Spine Fusion Elective Surgery in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 to less than 18 years
- American Society of Anesthesiologists (ASA) Physical Status 1 or 2
- Scheduled for posterior spine fusion surgery for idiopathic scoliosis
- Participant or legal guardian can speak and read English or Spanish
You will not qualify if you...
- Pregnant patients
- Allergy to methadone
- Prolonged QTc interval over 460 msec within 30 days before surgery
- Current treatment with known cytochrome P450 inhibitors listed in methadone labeling
- Opioid use within 30 days prior to surgery
- History of severe sleep apnea with apnea-hypopnea index greater than 10
- Significant liver, kidney, neurological disease, developmental delay, or other medical conditions per investigator discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
2
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Senthilkumar Sadhasivam, MD, MPH, MBA, FASA
CONTACT
D
Dayana Alsamsam, BSPS, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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