Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

NCT ID: NCT06067893

Last Updated: 2025-12-22

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-31

Brief Summary

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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

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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).

Conditions

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Spinal Fusion Adolescent Idiopathic Scoliosis

Keywords

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Pain management Narcotic sparing Pediatric Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Patient receives dexmedetomidine for 48 hours post-operatively

Interventions

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Dexmedetomidine

Patient receives dexmedetomidine for 48 hours post-operatively

Intervention Type DRUG

Normal Saline

Patient receives normal saline for 48 hours post-operatively

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nichole Doyle

OTHER

Sponsor Role lead

Responsible Party

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Nichole Doyle

Physican, M.D.

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 29149140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32240402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32696258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28298760 (View on PubMed)

Other Identifiers

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STUDY00002630

Identifier Type: -

Identifier Source: org_study_id