Clinical trial

Dexmedetomidine as a Pain Management Adjunct in the Pediatric Population Undergoing Posterior Spinal Fusion

Name
STUDY00002630
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2026-07-01
Trial end
2026-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Dexmedetomidine
Patient receives dexmedetomidine for 48 hours post-operatively
Arms:
Dexmedetomidine
Normal Saline
Patient receives normal saline for 48 hours post-operatively
Arms:
Control
Size
160
Primary endpoint
Opioid consumption
48 hours post-operatively
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2024-06-03

1 organization

1 product

1 drug

2 indications

Indication
Spinal Fusion