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CTRI Number  CTRI/2025/10/096422 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 23/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compartive study in cancer patient for pain management by treatment with morphine and morphine with ketamine in two groups 
Scientific Title of Study   Comparative study between efficacy of Morphine and Morphine with Ketamine in neuropathic pain in cancer palliative patient: Randomised prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RATNA GUPTA  
Designation  Junior Resident  
Affiliation  King George Medical University 
Address  Junior Resident Department of Anaesthesiology Gandhi Memorial and Associated Hospital King George Medical University
Shahmina Road Chowk Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  9760838488  
Fax    
Email  rrkg0520@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarita Singh 
Designation  Professor  
Affiliation  King George Medical University 
Address  Professor Department of Anaesthesiology Gandhi Memorial and associated Hospital King George Medical University
Shahmina Road Chowk Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  9415520080  
Fax    
Email  saritacsmmu@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sarita Singh 
Designation  Professor  
Affiliation  King George Medical University 
Address  Professor Department of Anaesthesiology Gandhi Memorial and associated Hospital King George Medical University
Shahmina Road Chowk Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  9415520080  
Fax    
Email  saritacsmmu@rediffmail.com  
 
Source of Monetary or Material Support  
Kinge george medical college shahmina road lucknow uttar pradesh Pin code 226003 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  Room No 1 Pain Clinic Department of Anaesthesiology, King George Medical University, Shahmina Road, Chowk, Lucknow. 226003 
Type of Sponsor  Government medical college 
 
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 Sarita Singh  King George medical college  Room No 1 Pain Clinic Department of Anaesthesiology King George Medical Universit Shahmina Road Chowk Lucknow 226003
Lucknow
UTTAR PRADESH 
9415520080

saritacsmmu@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George medical ethical commitee   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 
Comparator Agent  Morphine with ketamine  We will compaire the efficacy between iv morphine alone and morphine with ketamine via using pca pump 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient giving consent
2. All adult patients with age of 18-65 years admitted in palliative care IPD for neuropathic pain
3. All patients who have not been treated with any other anesthetic agent other than ketamine and morphine for neuropathic pain
4. Life expectancy more than 6 month 
 
ExclusionCriteria 
Details  1. Patient not giving consent
2. All patients who have been treated with any other anesthetic agent other than ketamine and morphine for neuropathic pain
3. Patient with renal disease
4. Very poor Glasgow coma scale
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the comparison of two sets of cases with neuropathic pain in cancer palliative patient   VAS score at 0 day, 1stday, 2ndday, 3rdday, 4thday, 5day, 1st week, 2ndweek, 4thweek, 3rdmonth,6month.
 
 
Secondary Outcome  
Outcome  TimePoints 
To study the patient pain relief , sedation, side effect, lifestyle quality improvement and reduction in visual analogue scale  VAS score at 0 day, 1stday, 2ndday, 3rdday, 4thday, 5day, 1st week, 2ndweek, 4thweek, 3rdmonth,6month.
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/11/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Background and Rationale

 Pain associated with cancer is a significant issue that affects patients’ quality of life and is difficult to treat. Refractory cancer pain is a significant proportion of patients, and pain management can enhance cancer therapy and improve patients’ quality of life. The World Health Organisation recommends a three-step analgesic ladder for managing pain associated with cancer. Opioids like morphine are typically used as the first-line treatment for neuropathic pain in advanced cancer patients. However, many patients may not receive complete pain relief. In some cases, a combination of ketamine and morphine has been shown to be safe and effective. Ketamine, a noncompetitive antagonist of the N-methy-D-aspartate (NMDA) receptor, has been shown to improve opioid-induced antinociception, lessen hyperalgesia, and decrease morphine intake when mixed with other drugs. However, it is unclear how opioid systems contribute to ketamine analgesia in humans. Ketamine’s anti-inflammatory properties, such as inhibiting the release of proinflammatory cytokines, may influence pain conditions. Morphine, an opioid analgesic, is a cornerstone in cancer pain management, targeting the central nervous system’s opioid receptors. However, neuropathic pain often involves mechanisms beyond opioid responsiveness. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has shown promise in enhancing opioid effectiveness and mitigating neuropathic pain by modulating central sensitization. This study aims to explore whether adding ketamine to morphine provides superior pain relief compared to morphine alone, considering factors like intensity, duration, and quality of pain.

AIM AND OBJECTIVES

Aim:

To evaluate the efficacy of morphine and morphine with ketamine in cancer patient suffering from neuropathic pain.

Objective

PRIMARY OBJECTIVE-To compare pain relief in suffering from neuropathic pain due to cancer with using VAS score at 0day, 1stday, 2ndday, 3rdday, 4thday, 5day, 1week, 2ndweek, 4thweek, 3rdmonth, 6month.

SECONDQRY OBJECTIVE-

To compare requirement of rescue analgesia between two groups.

To compare complication between two groups

MATERIAL AND METHODS

Study setting:

The study will be conducted in Department of Anesthesiology, in collaboration with Department of Surgical Oncology, King Georges Medical University, Lucknow. After getting approval from institutional ethical committee.

Study duration: One year

 

Study design: Randomized Prospective study

 Sample size

Sample size is calculated on the basis of variation in total morphine consumption for controlling pain in two study groups using the formula.

The required sample size determined from these parameters was 30 participants in each group.

 Inclusion Criteria:

 1. Patient giving consent

 2. All adult patients with the age of 18-6 palliative care IPD for neuropathic pain.

 3. All patients who have not been treated with agents other than ketamine plus morphine for neuropathic pain.

 4. Life expectancy more than 6 months.

 Exclusion Criteria:

 Patient not giving consent

All patients who have been treated with any other anaesthetic agents other than ketamine plus morphine for neuropathic pain.

 Patient with renal diseases.

 Very poor Glasgow coma scale patient.

 Methodology:

The study will be conducted at King Georges Medical University, Lucknow, after obtaining approval from the ethics committee and patient consent. Patients aged 18-65 with neuropathic pain due to cancer will be randomly divided into two groups: Group A, which uses 1mg morphine every 15 minutes, and Group B, which uses 1mg morphine every 15 minutes, with 0.30 to 0.45 microgram ketamine in fusion.

Group A will be consider as control group

We will admit patient for 5 days and give infusion

We will follow up the patient for upto 6month

Outcomes:

Primary outcome:

The study the comparison of two sets of cases with neuropathic pain in Cancer palliative patient.

Secondary outcome:

To study the patient pain relief, sedation, side effect, life style quality improvement and reduction in Visual Analouge Scale.

Statistical analysis:

SPSS 24th version version and MS Excel will be use for statistical analysis of the data. Continuous variables conforming to a normal distribution will be expressed as mean standard deviation. Counting data will be expressed as number and percentages. The ANOVA, unpaired t test or its non parametric equivalents will be used for within group analysis. The chisquare test will used to compare the proportion data between the groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P less than 0.05 will be considered to be statistically significant.

 


 
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