Adolescent Idiopathic Scoliosis, Spinal Fusion
Conditions
Keywords
Pain management, Narcotic sparing, Pediatric, Dexmedetomidine
Brief summary
This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.
Detailed description
Patients will assigned to one of two groups. Either the intervention group where they will receive a dexmedetomidine infusion at 0.2mcg/kg/hr for 24 hours post-operatively or the control group where they will receive a normal saline infusion for 24 hours post-operatively in addition to our hospitals standard pain management protocol. Pain scores will be recorded and patients will fill out a brief questionnaire on POD 1 about their pain control and side effects (pruritus, nausea, vomiting, drowsiness).
Interventions
DRUGDexmedetomidine
Patient receives dexmedetomidine for 48 hours post-operatively
DRUGNormal Saline
Patient receives normal saline for 48 hours post-operatively
Sponsors
Nichole Doyle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of idiopathic scoliosis * Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement
Exclusion criteria
* Known allergy to dexmedetomidine or any of the standard medications used intra or post operatively * Patients with a history of chronic pain currently taking opioids, TCA's, Gabapentinoids * Medical contraindications to administration of dexmedetomidine, unstable cardiac status, (prolonged Qtc, life threatening arrhythmias, use of digoxin) * Moya Moya disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| narcotic consumption | 48 hours post-operatively | measuring narcotic consumption in mg/kg per 24 hours in morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of side effects (nausea, vomiting, pruritus) | 48 hours post-operatively | Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis |
| Patient safety | 24 hours post-operatively | Need to discontinue infusion due to over sedation (Ramsey score of 4 or greater), bradycardia (HR \<50 sustained on 2 assessments or symptomatic), hypotension (SBP\<85 on 2 consecutive assessments or symptomatic). If these HR and SBP safety parameters are not appropriate for a participant based on baseline measurements or medical history new limits will be entered in a nurse communication. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNichole M Doyle, MD
Children's Mercy Hospital Kansas City
Outcome results
None listed