Clinical trial NCT05997134: Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome
Official title: Assessment of Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome: Randomized Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ketamine Infusion
Complex Regional Pain Syndromes
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: degree of chronic pain reduction
timeFrame: up to 3 months post infusion
Secondary outcomes:
measure: Reduction of the degree of chronic pain score
timeFrame: up to 3 months post infusion
measure: Side effects
timeFrame: up to 3 months post infusion
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-garbia
Study officials:
References: