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OpenTrials
Completed

NCT Number: NCT06402019

Dexmedetomidine Infusion Impact on 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha university

Banhā, Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

normal saline

Drug

Group went under multiple sessions of normal saline injection.

Primary outcomes

  1. The extent of reduction of consumed analgesics

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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