Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Study Overview
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Brief Summary
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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
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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 48 hours post-operatively or the control group where they will receive a normal saline infusion for 48 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 every 48hours about their pain control and side effects (pruritus, nausea, vomiting, drowsiness).

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

Conditions
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Spinal Fusion, Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol | Drug: Dexmedetomidine<br>* Patient receives dexmedetomidine for 48 hours post-operatively<br>|
| Placebo Comparator: Control<br>Patient receives normal saline infusion in addition to normal post-operative pain management protocol | Drug: Normal Saline<br>* Patient receives normal saline for 48 hours post-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | measuring opioid consumption in mg/kg per 24 hours in morphine equivalents | 48 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effects (nausea, vomiting, pruritus) | Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis | 48 hours post-operatively | 
| Patient safety | Need to discontinue infusion due to over sedation (Ramsey score of 4 or greater), bradycardia (HR change in beats per minute of 15% or greater or symptomatic bradycardia), hypotension (change of 15% or greater from baseline of MAP in mmHg or symptomatic) | 48 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Narcotic sparing, Pediatric, Dexmedetomidine