Dexmedetomidine Infusion Impact on Chronic Pain Patients

NCT06402019 | Completed

• 1 other identifier: RC.9.3.2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• The extent of reduction of consumed analgesics

  Necessity of Dexmedetomidine infusion as management procedure to the chronic pain patients

  6 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Drug: Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML)

Control Group

PLACEBO COMPARATOR

Drug: normal saline

Interventions

Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML) DRUG

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.

Intervention Group

normal saline DRUG

Group went under multiple sessions of normal saline injection.

Control Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical lecturer at Department of Anesthesia, Pain & ICU, Faculty of Medicine

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: May 7, 2024
• Study Start: March 1, 2023
• Primary Completion: September 22, 2023
• Study Completion: December 1, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

EG (1)