Dexmedetomidine Infusion Impact on Chronic Pain Patients

Repeated Dexmedetomidine Infusion is a Two-shot Weapon for Pain and Pain-induced Mood Disorders in Chronic Pain Patients

Chronic pain (CP) was defined as pain experienced daily or on most days and induced restriction of at least one activity. CP is one of the commonest complaints confronted in outpatient clinics and constitutes a challenge for all medical provisions. CP is a multifaceted condition; postoperative CP is frequently encountered in clinical practice and may be of debilitating severity leading to worse quality of life (QOL) especially CP with a neuropathic component as post-mastectomy pain syndrome and post-amputation pain and chronic post-sternotomy pain that seriously impacts patients' QOL and affects patient recovery till 12 months after cardiac surgery. Chronic musculoskeletal pain as defined by the International Pain Association is the persistent or recurrent pain involving spine, bones, joints, and/or musculo-soft tissue.

Chronic pain was considered as a long-lasting stressor that might induce disordered mood varying between depression and anxiety with consequent challenge of this combination on treatment outcomes and consumption of health resources. This necessitated psychological screening of CP patient to identify and manage patients with disordered mood to improve CP treatment outcomes.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML); Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qalyoubia
    • Banhā, Qalyoubia, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with multiple-level spinal canal stenosis who refused surgical management.

Exclusion Criteria:

• Patients with other causes for CP;
• maintained on opioid analgesia;
• had cardiac lesions;
• maintained on antihypertensive therapy;
• hepatic impairment;
• Patients can't attend the clinic to complete the course of Dexmedetomidine infusion sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Drug: normal saline; Group went under multiple sessions of normal saline injection.
Active Comparator: Intervention Group	Drug: Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML); Group went under multiple sessions of Dexmedetomidine infusion for 10 sessions; The infusion was provided under non-invasive monitoring for heart rate (HR) and mean arterial pressure (MAP). The infusion rate was adjusted to maintain HR in range of 60-80 beats/min and MAP in range of 65-75 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The extent of reduction of consumed analgesics	Necessity of Dexmedetomidine infusion as management procedure to the chronic pain patients	6 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 13, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: RC.9.3.2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No