Using intrathecal hydromorphone for pain control in pediatric scoliosis surgery
Identification of the Optimal Analgesic Dose of Intrathecal Hydromorphone for Pediatric Patients Undergoing Posterior Spine Surgery for Idiopathic Scoliosis
This study is testing the best dose of a pain medication called hydromorphone for kids having surgery for scoliosis to see how well it can relieve their pain without causing too many side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05552443 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal dose of intrathecal hydromorphone for managing pain in pediatric patients undergoing posterior spinal surgery for idiopathic scoliosis. Utilizing a sequential coin-based up-down dose allocation method, the study will start with a dose of 3.5 mcg/kg and adjust based on the pain control effectiveness observed in previous participants. The goal is to identify the effective dose that minimizes side effects while ensuring adequate pain relief, defined as a Numeric Rating Scale (NRS) score of 5 or lower within the first 18 hours post-administration.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients scheduled for posterior spinal surgery to correct idiopathic scoliosis.
Not a fit: Patients with pre-existing chronic pain, elevated pre-surgical pain scores, or those requiring pre-surgical opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for pediatric patients undergoing scoliosis surgery.
How similar studies have performed: Previous studies have explored intrathecal opioid administration for pain control, but this specific approach to dose optimization in pediatric scoliosis surgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Undergoing spinal surgery with a posterior approach for idiopathic scoliosis. Exclusion criteria: * Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included. * Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included. * Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn Handlogten, MD — Mayo Clinic
- Study coordinator: Handlogten
- Email: clinicaltrialsoffice@mayo.edu
- Phone: 507-255-5123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.