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Enrolling by invitation NCT06067893

Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Phase IV Interventional Spinal Fusion Adolescent Idiopathic Scoliosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine, Normal Saline.
Who it may be relevant to
Registry conditions: Spinal Fusion, Adolescent Idiopathic Scoliosis. Basic parameters: 10 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 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).

Interventions

  • Drug Dexmedetomidine
    Patient receives dexmedetomidine for 48 hours post-operatively
  • Drug Normal Saline
    Patient receives normal saline for 48 hours post-operatively

Primary outcome measures

  • narcotic consumption [Time frame: 48 hours post-operatively]
Secondary outcome measures (2)
  • Incidence of side effects (nausea, vomiting, pruritus) [Time frame: 48 hours post-operatively]
  • Patient safety [Time frame: 24 hours post-operatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Mercy Hospital — Kansas City

Publications

  • 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. PMID 29149140
  • 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. PMID 32240402
  • 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. PMID 32696258
  • 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. PMID 28298760

Identifiers

NCT: NCT06067893 · STUDY00002630

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗