Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06067893
• Other study ID #: STUDY00002630
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Nichole M Doyle, MD
• Phone: 316-218-2454
• Email: nmdoyle[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis
• Spinal Fusion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	measuring opioid consumption in mg/kg per 24 hours in morphine equivalents	48 hours post-operatively
Secondary	Incidence of side effects (nausea, vomiting, pruritus)	Assessing the incidence of side effects (nausea, vomiting, pruritus) using a questionnaire and documented episodes of emesis	48 hours post-operatively
Secondary	Patient safety	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)	48 hours post-operatively