Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

• Sponsor: Children's Mercy Hospital Kansas City (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06067893
• Collaborator: (none)
• Enrollment: 160
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Fusion; Adolescent Idiopathic Scoliosis	Drug: Dexmedetomidine; Drug: Normal Saline	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dexmedetomidine as a Pain Management Adjunct in the Pediatric Population Undergoing Posterior Spinal Fusion
• Anticipated Study Start Date: Mar 1, 2024
• Anticipated Primary Completion Date: Mar 1, 2026
• Anticipated Study Completion Date: Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol	Drug: Dexmedetomidine; Patient receives dexmedetomidine for 48 hours post-operatively
Placebo Comparator: Control Patient receives normal saline infusion in addition to normal post-operative pain management protocol	Drug: Normal Saline; Patient receives normal saline for 48 hours post-operatively

Outcome Measures

Primary Outcome Measures

1. Opioid consumption [48 hours post-operatively]

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

Secondary Outcome Measures

1. 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

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Mercy Hospital Kansas City

Investigators

• Principal Investigator: Nichole M Doyle, MD, Children's Mercy Hospital Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Nichole Doyle, Physican, M.D., Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT06067893
• Other Study ID Numbers: STUDY00002630
• First Posted: Oct 5, 2023
• Last Update Posted: Oct 5, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Nichole Doyle, Physican, M.D., Children's Mercy Hospital Kansas City: Pain management; Narcotic sparing; Pediatric; Dexmedetomidine
• Additional relevant MeSH terms: Scoliosis; Dexmedetomidine

Study Results

No Results Posted as of Oct 5, 2023