Back to resultsThree Regimens of Ketamine Infusion in Complex Regional Pain Syndrome
Primary Purpose
Ketamine Infusion, Complex Regional Pain Syndromes
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Ketamine
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Ketamine 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.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm 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
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 .
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reduction of the degree of chronic pain score
Numerical rating scales (NRS) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable"
Side effects
Headache, Nausea and vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05997134
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketamine Infusion, Complex Regional Pain Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm 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
Arm Title
Group B
Arm Type
Experimental
Arm 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 .
Arm Title
Group C
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention 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 .
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention 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
Primary Outcome Measure Information:
Title
degree of chronic pain reduction
Description
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.
Time Frame
up to 3 months post infusion
Secondary Outcome Measure Information:
Title
Reduction of the degree of chronic pain score
Description
Numerical rating scales (NRS) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable"
Time Frame
up to 3 months post infusion
Title
Side effects
Description
Headache, Nausea and vomiting
Time Frame
up to 3 months post infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-garbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aml M Abo elsafa, MBBCh
Phone
+20 101 260 2853
Email
amlabouelsafa67@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashraf A Alzeftawy, MD
First Name & Middle Initial & Last Name & Degree
Mohamed A Afandy, MD
First Name & Middle Initial & Last Name & Degree
Hesham I El Tatawy, Msc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
after the end of study for one year
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author
Learn more about this trial
Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome
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