Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome

NCT05997134 | Unknown Phase 4 DMC

• 1 other identifier: 36264MS44/1/23
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Ketamine Infusion; Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• degree of chronic pain reduction

  using Brief Pain Inventory short form (BPI-SF) questionnaire. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.

  up to 3 months post infusion

Secondary Outcomes (2)

• Reduction of the degree of chronic pain score

  up to 3 months post infusion

• Side effects

  up to 3 months post infusion

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: Ketamine

Group B

EXPERIMENTAL

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 .

Drug: Ketamine

Group C

EXPERIMENTAL

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

Drug: Ketamine

Interventions

Ketamine DRUG

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 .

Group A

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-garbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of anesthesiology, surgical intensive care and pain medicine

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: August 30, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: after the end of study for one year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)