Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)
Launched by SENTHIL SADHASIVAM · May 4, 2022
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to manage pain for children who are having spine surgery, specifically a procedure called Posterior-Lateral Spinal Fusion. The goal is to create a personalized pain relief plan that helps reduce the use of opioids, which are strong pain medications that can have serious side effects. By improving how pain is managed before, during, and after surgery, the researchers hope to make the experience safer and more comfortable for young patients.
To participate, children aged 10 to 21 who are in good health (ASA physical status 1 to 3) and are scheduled for this specific spinal surgery can enroll. They should be receiving opioids during their hospital stay and will need to have a prescription for opioids when they go home. However, children with serious illnesses, severe pain before surgery, or a history of opioid misuse will not be eligible. Participants can expect to receive tailored pain management strategies, and their progress will be monitored closely throughout the study. This trial is currently recruiting participants, and it offers a chance to contribute to important research that could improve pain management for future patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Children ages 10 to 21
- • ASA physical status 1 to 3
- • Undergoing Posterior-Lateral Spinal Fusion
- • Receives in-patient opioids
- • Prescribed opioids at discharge
- Exclusion Criteria:
- • Serious illness
- • Preoperative severe pain
- • Preoperative opioid use or misuse
About Senthil Sadhasivam
Senthil Sadhasivam is a dedicated clinical trial sponsor with a focus on advancing medical research through innovative and rigorous study designs. Committed to improving patient outcomes, Sadhasivam leverages extensive expertise in clinical methodologies and regulatory compliance to facilitate the development of new therapies. By fostering collaborations with healthcare professionals and research institutions, he aims to contribute to the understanding of complex medical conditions and enhance treatment options available to patients. With a strong emphasis on ethical practices and patient safety, Senthil Sadhasivam is positioned as a reliable partner in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pittsburgh, Pennsylvania, United States
Indianapolis, Indiana, United States
Pittsburgh, Pennsylvania, United States
San Francisco, California, United States
Patients applied
Trial Officials
Senthilkumar Sadhasivam, MD, MPH
Principal Investigator
University of Pittsburgh
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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