Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Nichole Doyle

Status and phase: Invitation-only; Phase 4

Conditions: Spinal Fusion; Adolescent Idiopathic Scoliosis

Treatments: Drug: Dexmedetomidine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06067893

STUDY00002630

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol

Treatment:

Drug: Dexmedetomidine

Control

Placebo Comparator group

Description:

Patient receives normal saline infusion in addition to normal post-operative pain management protocol

Treatment:

Drug: Normal Saline