What this study is
The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.
What's being tested
- Opioid-Free/Opioid-Avoidant
Intervention · DRUG
Managed post-operatively with an opioid-free pain regimen which will include: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound Gabapentin PO 300 mg TID x 30 days Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs Acetaminophen PO dosed per body weight and discharged home with PO tabs Diazepam PO dosed per body weight during stay and discharged home with PO tabs Non-medicinal therapy: Ice, Aromatherapy, Music therapy, Pet therapy, Early mobilization and PT
- Opioid-Containing
Intervention · DRUG
Managed post-operatively with a traditional opioid containing pain regimen including: Intrafascial injection of clonidine, epinephrine, ropivacaine, and toradol solution, diluted to 100mL and injected during closure of wound Post-operative morphine IV for breakthrough pain Oral narcotic (hydrocodone/acetaminophen) Gabapentin PO 300 mg TID x 30 days Toradol IV dosed per body weight, max 30 mg q 6 hours for 24-28 hours Ibuprofen PO dosed per body weight q 6-8 hours once toradol discontinued and discharged home with PO tabs Acetaminophen PO dosed per body weight and discharged home with PO tabs Diazepam PO dosed per body weight during stay and discharged home with PO tabs Non-medicinal therapy: Ice, Early mobilization and PT
Study details
- Official title
- Comparison of Opioid-Free Versus Traditional Opioid-Containing Postoperative Pain Management Pathways for Adolescent Idiopathic Scoliosis
- Sponsor
- OrthoCarolina Research Institute, Inc.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Enrolling
- 58 people
- Starts
- 2025-10-14
- Est. completion
- 2027-12-31
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 20 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Pediatric patients (10-20 years of age at the time of surgery)
- Diagnosis of idiopathic scoliosis
- Undergoing primary instrumented PSF
You can't join if
- Age <10 years or >20 years at time of surgery
- Patients with non-idiopathic scoliosis etiology, ie neuromuscular or syndromic scoliosis
- Patients undergoing non-fusion spinal surgeries, ie growing rods or tethering
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOrthoCarolina Research Institute
Charlotte, North Carolina, United States
Study team
Sponsor
OrthoCarolina Research Institute, Inc.
Study ID 9209
Principal investigator
Michael Paloski, DO
OrthoCarolina Research Institute, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.