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Dexmedetomidine Infusion Impact on Chronic Pain Patients

B

Benha University

Status

Completed

Conditions

Chronic Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06402019
RC.9.3.2024

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Intervention Group
Active Comparator group
Treatment:
Drug: Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML)
Control Group
Placebo Comparator group
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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