Dexmedetomidine Infusion Impact on Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06402019
• Other study ID #: RC.9.3.2024
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• normal saline
Group went under multiple sessions of normal saline injection.

Locations

Country	Name	City	State
Egypt	Benha university	Banha	Qalyoubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The extent of reduction of consumed analgesics	Necessity of Dexmedetomidine infusion as management procedure to the chronic pain patients	6 months