Clinical trial

Assessment of Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome: Randomized Prospective Comparative Study

Name

36264MS44/1/23

Description

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

Trial arms

Trial start

2023-08-30

Estimated PCD

2024-09-01

Trial end

2024-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Ketamine

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 .

Arms:

Group A

Ketamine

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

Arms:

Group B

Ketamine

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

Arms:

Group C

Size

Primary endpoint

degree of chronic pain reduction

up to 3 months post infusion

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

Updated at

2023-08-31

1 organization

1 drug

2 indications

Organization

Tanta University

Drug

Ketamine

Indication

Ketamine Infusion

Indication

Complex Regional Pain Syndromes