Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome

Tanta University

Status and phase: Enrolling; Phase 4

Conditions: Complex Regional Pain Syndromes; Ketamine Infusion

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05997134

36264MS44/1/23

Details and patient eligibility

About

To evaluate the efficacy of three regimens of sub anesthetic dose of ketamine infusion in relieving chronic refractory pain in patients with complex regional pain syndrome

Full description

Ketamine N-methyl-D-aspartate (NMDA) receptor blocker that has recently been studied for its analgesic effect is a phencyclidine or phenyl cyclohexyl piperidine (PCP) derivative that initially became commercially available for human use in 1970 as a rapid-acting intravenous (IV) anesthetic. It is currently classified by the Food and Drug Administration (FDA) as an anesthetic induction agent in doses ranging from 1 to 4.5 mg/kg.

Ketamine has proven to be a desirable drug, despite of its induction dissociative effects and abuse potential. It is favorable due to its short half-life and lack of clinically significant respiratory depression. In addition to its anesthetic effects, ketamine has analgesic, anti-inflammatory, and antidepressant activities.

Enrollment: 75 estimated patients

Sex: All

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged more than 21 years old of both sexes with American Standards Association I ,II.
• Patients diagnosed as ( CRPS) based on Budapest criteria
• The average daily pain intensity required on (NRS) is 7 or more for at least 3 months despite of standard therapy which includes: (pharmacologic therapy as non steroidal anti- inflammatory drugs (NSAIDs), antiepileptic (AEDs), antidepressants), as well as physical therapy and psychiatric care

Exclusion criteria

• patients refusal
• Patients with unstable psychological or psychiatric conditions, including : untreated bipolar disorder, post-traumatic stress disorder, major depression , severe personality disorder and psychotic illness.
• Patients have recently undergone major interventional pain procedures, such as nerve blocks or implantable therapies within 3 months of enrollment.
• Patients with known drug dependency or substance use disorder specifically related to ketamine or other psycho-stimulant drugs.
• Patients with previous severe reactions, contraindication or allergy to ketamine.
• Patients with cardiovascular disease (hypertension, arrhythmia), hepatic, renal or other organ impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Group A

Experimental group

Description:

patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Group B

Experimental group

Description:

patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days .

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine

Group C

Experimental group

Description:

patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days

Treatment:

Drug: Ketamine

Drug: Ketamine

Drug: Ketamine