Clinical trial NCT06067893: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Spinal Fusion
Adolescent Idiopathic Scoliosis
Keywords: Pain management
Narcotic sparing
Pediatric
Dexmedetomidine
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 160
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Opioid consumption
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: Incidence of side effects (nausea, vomiting, pruritus)
timeFrame: 48 hours post-operatively
measure: Patient safety
timeFrame: 48 hours post-operatively
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Nichole M Doyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.