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CTRI Number  CTRI/2025/05/087182 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 19/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study on using low dose of intravenous ketamine to manage severe cancer pain in patients with advanced stages of the cancer. 
Scientific Title of Study   A Prospective Observational study on the efficacy and safety of low dose intravenous ketamine in refractory cancer pain in patients suffering from advanced cancer at SMS Medical College and Hospital, Jaipur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DEEPINDER KAUR GHERA 
Designation  RESIDENT MD (PALLIATIVE MEDICINE ) 
Affiliation  SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS 
Address  SAWAI MAN SINGH MEDICAL COLLEGE PALLIATIVE MEDICINE DEPARTMENT JAIPUR RAJASTHAN
resident hostel, SMS hospital jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  7657823995  
Fax    
Email  deepinder2329@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR YOGENDRA SINGHAL 
Designation  PROFESSOR 
Affiliation  SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR 
Address  Department of palliative medicine S.M.S Medical College ,Jaipur (Rajasthan ) India
Department of palliative medicine S.M.S Medical College ,Jaipur (Rajasthan ) India
Jaipur
RAJASTHAN
302004
India 
Phone  9414850381  
Fax    
Email  singhalyogi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR YOGENDRA SINGHAL 
Designation  PROFESSOR 
Affiliation  SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR 
Address  Department of palliative medicine S.M.S Medical College ,Jaipur (Rajasthan ) India
Department of palliative medicine S.M.S Medical College ,Jaipur (Rajasthan ) India
Jaipur
RAJASTHAN
302004
India 
Phone  9414850381  
Fax    
Email  singhalyogi@yahoo.co.in  
 
Source of Monetary or Material Support  
DRUG KETAMINE IS AVAILABLE FREE OF COST (FREE MEDICINE) AVAILABLE UNDER SCHEME OF MUKHYAMANTRI NISHULK DAVA YOJANA IN S.M.S HOSPITAL JAIPUR (GOVERMENT OF RAJASTHAN) 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr DEEPINDER KAUR GHERA  S.M.S HOSPITAL JAIPUR  RKBC fabricated ward first floor Department of palliatrive mediicne S.M.S hospital jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 7657823995

deepinder2329@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS ,JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age between 18 and 65 years.
2. Registered in Palliative Medicine Department.
3. Suffering from a histologically diagnosed cancer.
4. Patients having nociceptive or neuropathic pain refractory to opioids,numerical rating score greater than 7/10
5. Patient giving written informed consent for this study.
6. Patient having more than 180 mg morphine in 24 hours with inadequate pain relief.  
 
ExclusionCriteria 
Details  1. History of allergy or intolerance to ketamine.
2. History of uncontrolled hypertension, heart disease, liver and renal
disease, glaucoma, primary and malignant brain lesions.
3. Patients on psychiatric treatment
4. Subjects scheduled to receive radiotherapy (RT) to a site of pain
during the study period, or who have received RT to a site of pain
within 2 weeks before study entry.
5. Subjects scheduled to undergo surgical treatment during the study
period are likely to affect pain.
6. Subjects on or starting chemotherapy if there is a significant
expectation of that therapy affecting pain.
7. Patients are included in other study group  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess efficacy( in terms of changing NRS) of low dose
intravenous ketamine in opioid refractory cancer pain in patients
suffering from advanced cancer.
2. To assess safety (in terms of adverse effects )of low dose
intravenous ketamine in opioid refractory cancer pain in patients
suffering from advanced cancer 		 1. The first follow up will be done at 2nd week after discharge pain
intensity and dose of opioid.
2. The second follow up will be done at 4th week after discharge
regarding pain intensity and dose of opioid 
 
Secondary Outcome  
Outcome  TimePoints 
adverse events & sustainability of ketamine effect.  at time of discharge at second week & fourth week of discharge. 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Cancer pain is a prevalent issue, with around 50.7% of patients experiencing it across all stages. Refractory cancer pain persists despite standard treatments like opioids and non-pharmacological methods, significantly impacting quality of life. Opioids are a cornerstone in pain management but can cause side effects, including opioid-induced hyperalgesia (OIH), where pain increases with higher doses.

Ketamine, at sub-anaesthetic doses, shows potential in managing such pain. By acting as an NMDA receptor antagonist, it addresses central sensitization, reverses opioid tolerance, and alleviates hyperalgesia and allodynia, making it a promising option for improving pain relief in cancer patients.
So, with this background of knowledge present study aims to assess the effectiveness and safety of low-dose intravenous ketamine in managing opioid-refractory cancer pain in individuals with advanced cancer disease.
 
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