Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	10 Years - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06067893
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Mercy Hospital Kansas City
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nichole M Doyle, MD
Principal Investigator Affiliation	Children's Mercy Hospital Kansas City
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Fusion, Adolescent Idiopathic Scoliosis

Additional Details

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).

Arms & Interventions

Arms

Experimental: Dexmedetomidine

Patient receives low dose dexmedetomidine infusion in addition to normal post-operative pain management protocol

Placebo Comparator: Control

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

Interventions

Drug: - Dexmedetomidine

Patient receives dexmedetomidine for 48 hours post-operatively

Drug: - Normal Saline

Patient receives normal saline for 48 hours post-operatively

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Mercy Hospital, Kansas City, Missouri

Status

Address

Children's Mercy Hospital

Kansas City, Missouri, 64108

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