Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

NCT06067893 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: STUDY00002630
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fusion; Adolescent Idiopathic Scoliosis

Keywords

Pain management; Narcotic sparing; Pediatric; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• narcotic consumption

  measuring narcotic consumption in mg/kg per 24 hours in morphine equivalents

  48 hours post-operatively

Secondary Outcomes (2)

• Incidence of side effects (nausea, vomiting, pruritus)

  48 hours post-operatively

• Patient safety

  24 hours post-operatively

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

Patient receives dexmedetomidine for 48 hours post-operatively

Dexmedetomidine

Normal Saline DRUG

Patient receives normal saline for 48 hours post-operatively

Control

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of idiopathic scoliosis
• Undergoing a posterior spinal fusion of at least 5 levels with both thoracic and lumbar involvement

You may not qualify if:

• 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

Sponsors & Collaborators

• Nichole Doyle: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nichole M Doyle, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physican, M.D.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)