Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Phase 4

• Conditions: Adolescent Idiopathic Scoliosis; Spinal Fusion
• Interventions: Drug: Normal Saline; Drug: Dexmedetomidine

• Registration Number: NCT06067893
• Lead Sponsor: Children's Mercy Hospital Kansas City

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).

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal Saline	Patient receives normal saline infusion in addition to normal post-operative pain management protocol
Dexmedetomidine	Dexmedetomidine	Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol

Primary Outcome Measures

Name	Time	Method
Opioid consumption	48 hours post-operatively	measuring opioid consumption in mg/kg per 24 hours in morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects (nausea, vomiting, pruritus)	48 hours post-operatively	Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis
Patient safety	48 hours post-operatively	Need to discontinue infusion due to over sedation (Ramsey score of 4 or greater), bradycardia (HR change in beats per minute of 15% or greater or symptomatic bradycardia), hypotension (change of 15% or greater from baseline of MAP in mmHg or symptomatic)

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States