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Enrolling by Invitation

NCT Number: NCT06067893

Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

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.

Enrolling by Invitation

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Key information

Conditions

Spinal Fusion Adolescent Idiopathic Scoliosis Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Patient receives dexmedetomidine for 48 hours post-operatively

normal saline

Drug

Patient receives normal saline for 48 hours post-operatively

Primary outcomes

  1. narcotic consumption

    Time frame: 48 hours post-operatively

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

Secondary outcomes

  1. Incidence of side effects (nausea, vomiting, pruritus)

    Time frame: 48 hours post-operatively

    Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis

  2. Patient safety

    Time frame: 24 hours post-operatively

    Need to discontinue infusion due to over sedation (Ramsey score of 4 or greater), bradycardia (HR <50 sustained on 2 assessments or symptomatic), hypotension (SBP<85 on 2 consecutive assessments or symptomatic). If these HR and SBP safety parameters are not appropriate for a participant based on baseline measurements or medical history new limits will be entered in a nurse communication.

Sponsors and collaborators

Lead sponsor

Nichole Doyle

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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