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Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Primary Purpose

Spinal Fusion, Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Normal Saline
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fusion focused on measuring Pain management, Narcotic sparing, Pediatric, Dexmedetomidine

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dexmedetomidine

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Opioid consumption
    measuring opioid consumption in mg/kg per 24 hours in morphine equivalents

    Secondary Outcome Measures

    Incidence of side effects (nausea, vomiting, pruritus)
    Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis
    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)

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    September 28, 2023
    Sponsor
    Children's Mercy Hospital Kansas City
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06067893
    Brief Title
    Low Dose Dexmedetomidine as a Postoperative Pain Adjunct
    Official Title
    Dexmedetomidine as a Pain Management Adjunct in the Pediatric Population Undergoing Posterior Spinal Fusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    March 2026 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Mercy Hospital Kansas City

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Fusion, Adolescent Idiopathic Scoliosis
    Keywords
    Pain management, Narcotic sparing, Pediatric, Dexmedetomidine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine
    Arm Type
    Experimental
    Arm Description
    Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Patient receives normal saline infusion in addition to normal post-operative pain management protocol
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    Patient receives dexmedetomidine for 48 hours post-operatively
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Intervention Description
    Patient receives normal saline for 48 hours post-operatively
    Primary Outcome Measure Information:
    Title
    Opioid consumption
    Description
    measuring opioid consumption in mg/kg per 24 hours in morphine equivalents
    Time Frame
    48 hours post-operatively
    Secondary Outcome Measure Information:
    Title
    Incidence of side effects (nausea, vomiting, pruritus)
    Description
    Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis
    Time Frame
    48 hours post-operatively
    Title
    Patient safety
    Description
    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)
    Time Frame
    48 hours post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nichole M Doyle, MD
    Phone
    316-218-2454
    Email
    nmdoyle@cmh.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julia Leamon, MSN, RN, CPN
    Email
    jleamon@cmh.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nichole M Doyle, MD
    Organizational Affiliation
    Children's Mercy Hospital Kansas City
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Deidentified patient data available on request
    Citations:
    PubMed Identifier
    29149140
    Citation
    Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596.
    Results Reference
    background
    PubMed Identifier
    32240402
    Citation
    Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.
    Results Reference
    background
    PubMed Identifier
    32696258
    Citation
    Naduvanahalli Vivekanandaswamy A, Prasad Shetty A, Mugesh Kanna R, Shanmuganathan R. An analysis of the safety and efficacy of dexmedetomidine in posterior spinal fusion surgery for adolescent idiopathic scoliosis: a prospective randomized study. Eur Spine J. 2021 Mar;30(3):698-705. doi: 10.1007/s00586-020-06539-9. Epub 2020 Jul 21.
    Results Reference
    background
    PubMed Identifier
    28298760
    Citation
    Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232.
    Results Reference
    background

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    Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

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