Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)
Senthil Sadhasivam
Summary
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.
Description
SPECIFIC AIMS. 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. The long-term goal is to proactivel…
Eligibility
- Age range
- 10–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 10 - \< 18 years 2. American Society of Anesthesiologists (ASA) Physical Status 1 or 2 3. Undergoing PSF for idiopathic scoliosis 4. Participant or legal guardian can speak and read English or Spanish Exclusion Criteria: 1. Pregnant patients 2. Methadone allergy 3. Preoperative prolonged QTc more than 460 msec (-30 days to 0 day) 4. 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. r…
Interventions
- DrugMethadone based ERAS
Methadone intervention includes intraoperative intravenous methadone (1st dose: 0.1 mg/kg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg/kg up to a maximum of 5 mg administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral doses of methadone (0.1 mg/kg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.
- DrugNon-methadone based group
Non-methadone intervention includes standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. Postoperative pain medication is recommended when reported pain level is considered moderate or higher (≥4 on NRS and FLACC).
Locations (2)
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- UPMC Children's HospitalPittsburgh, Pennsylvania