Evaluation of Analgesia for Spine Fusion Elective Surgery in Children

ConditionIdiopathic Scoliosis

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age10-18

SponsorSenthil Sadhasivam

About this trial

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.

Eligibility criteria

Qualifiers

Age 10 - < 18 years

American Society of Anesthesiologists (ASA) Physical Status 1 or 2

Undergoing PSF for idiopathic scoliosis

Participant or legal guardian can speak and read English or Spanish

Disqualifiers

Pregnant patients

Methadone 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)

Trial design

Treatments tested in this trial

Methadone based ERAS
Non-methadone based group

Treatment groups

500 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Senthil Sadhasivam

Lead sponsor

University of Pittsburgh

Sponsor institution

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov