Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

Launched by SENTHIL SADHASIVAM · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new method using methadone can help children recover after spinal surgery for a condition called idiopathic scoliosis, which is a sideways curvature of the spine. The study will compare this new recovery plan to the current standard care that children usually receive after surgery. To decide who gets which treatment, children will be randomly assigned to one of the two groups, similar to flipping a coin.

The trial is open to children aged 10 to 17 who are scheduled for spinal surgery. However, there are certain conditions that might prevent some children from participating, such as having severe health issues or allergies to certain medications. While the study is not yet recruiting participants, families can expect their child to receive either the new methadone-based recovery approach or the usual care after surgery, contributing to important research that could improve recovery outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants aged 10-\<18yrs for PSF trial
• • ASA physical status 1\&2
• • Undergoing PSF for idiopathic scoliosis
• • Participant or legal guardian can speak and read English or Spanish
• Exclusion Criteria:
• • Pregnant patients
• • American Society of Anesthesiologists (ASA) Physical Status 3 or above
• • Methadone/oxycodone 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 (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness)
• • Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator