Evaluating ketamine infusion regimens for chronic pain relief in complex regional pain syndrome
Assessment of Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome: Randomized Prospective Comparative Study
This study is testing whether different doses of ketamine infusions can help people with complex regional pain syndrome who have chronic pain that hasn't improved with other treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years to 40 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-garbia) |
| Trial ID | NCT05997134 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of three different regimens of sub-anesthetic doses of ketamine infusion in alleviating chronic refractory pain in patients diagnosed with complex regional pain syndrome (CRPS). Ketamine, known for its NMDA receptor-blocking properties, has been recognized for its analgesic effects, making it a potential treatment option for patients who have not responded to standard therapies. Participants will be monitored for pain relief and any side effects associated with the treatment. The study will include patients who have experienced significant pain for at least three months despite conventional treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 21 years old diagnosed with CRPS and experiencing severe pain despite standard therapies.
Not a fit: Patients with unstable psychological conditions or those who have recently undergone major pain interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic pain due to complex regional pain syndrome.
How similar studies have performed: Other studies have shown promising results with ketamine for pain management, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta, El-garbia
- Tanta University — Tanta, El-garbia, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.