Actively Recruiting
Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)
Led by Senthil Sadhasivam · Updated on 2026-05-05
500
Participants Needed
2
Research Sites
30 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
Researchers are studying pain management for children aged 10 to under 18 years undergoing elective surgery for idiopathic scoliosis, specifically posterior spine fusion (PSF). This study aims to evaluate the safety and effectiveness of a multidose methadone-based enhanced recovery after surgery (ERAS) protocol compared to standard short-acting opioid pain treatments. The goal is to improve surgical pain control while reducing opioid-related side effects and long-term opioid use in children. The study involves two treatment groups: one group will receive a standardized multidose methadone-based analgesia including intraoperative intravenous doses before and after surgery, followed by additional doses every 12 hours until hospital discharge. The other group will receive the current standard opioid pain management without methadone. Researchers will also use genetic and clinical data to develop personalized dosing strategies for methadone and oxycodone to optimize pain relief and minimize risks. Participants will be monitored closely during the postoperative period with assessments of pain levels, opioid use, respiratory function, nausea, sedation, heart rhythm, and length of hospital stay. Follow-up will include evaluation of persistent opioid use, chronic postsurgical pain, and opioid dependence up to three months after surgery. The study will enroll approximately 1000 children across multiple centers, with detailed genetic and clinical data collection to personalize future pain management.
CONDITIONS
Brief 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...
- Pregnancy
- Known allergy to methadone
- Prolonged QTc interval over 460 msec within 30 days before surgery
- Use of certain cytochrome P450 inhibitors (e.g., macrolides, azole antifungals, protease inhibitors, SSRIs) within 30 days before surgery
- Opioid use within 30 days before surgery
- History of severe sleep apnea with apnea-hypopnea index greater than 10
- Significant liver, kidney, neurological disease, developmental delay, or other serious medical conditions as determined by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge (approximately 5 days post-surgery)
Participants undergo posterior spine fusion surgery and receive either a methadone-based analgesia protocol or standard opioid analgesia. The methadone group receives intraoperative intravenous methadone doses and up to 4 additional doses every 12 hours postoperatively before discharge.
1 surgery and inpatient hospital stay with multiple postoperative assessments
Duration - Up to 3 months post-surgery
Participants are monitored for postoperative outcomes including pain, opioid use, respiratory depression, nausea and vomiting, sedation, QTc prolongation, length of hospital stay, and long-term effects such as persistent opioid use, chronic postsurgical pain, and opioid dependence.
Visits or assessments at 1 week, 1 month, and 3 months post-surgery
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
D
Dayana Alsamsam, BSPS, MSc
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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