Low Dose Dexmedetomidine as a Postoperative Pain Adjunct
NCT ID: NCT06067893
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
160 participants
INTERVENTIONAL
2024-07-01
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Patient receives normal saline infusion in addition to normal post-operative pain management protocol
Normal Saline
Patient receives normal saline for 48 hours post-operatively
Dexmedetomidine
Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol
Dexmedetomidine
Patient receives dexmedetomidine for 48 hours post-operatively
Interventions
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Dexmedetomidine
Patient receives dexmedetomidine for 48 hours post-operatively
Normal Saline
Patient receives normal saline for 48 hours post-operatively
Eligibility Criteria
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Inclusion Criteria
* Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement
Exclusion Criteria
* 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
10 Years
21 Years
ALL
Yes
Sponsors
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Nichole Doyle
OTHER
Responsible Party
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Nichole Doyle
Physican, M.D.
Principal Investigators
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Nichole M Doyle, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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STUDY00002630
Identifier Type: -
Identifier Source: org_study_id